Original article

Real-world utilization pattern of dydrogesterone in

7287 Indian women with obstetric and gynecological
conditions: data from multicentric, retrospective study
Jaydeep Tank1
[Link]

Sanjay Gupte2
[Link]

Purna Chandra Mahapatra3

[Link]

Jayanthi Reddy4
[Link]

Pratima Mittal5
[Link]

Ashish Kumar Mukhopadhyay6

[Link]

Lila Vyas7
[Link]

Achla Batra5
[Link]

Mahesh Gupta8
[Link]

Sunita Tandulwadkar9
[Link]
How to cite Sunita Chandra10
Tank J, Gupte S, Mahapatra PC, Reddy [Link]
J, Mittal P, Mukhopadhyay AK, et
al. Real-world utilization pattern of Vidya Bhat11
dydrogesterone in 7287 Indian women ([Link]
with obstetric and gynecological
conditions: Data from multicentric,
Kawita Bapat12
[Link]
retrospective study. Rev Bras Ginecol
Obstet. 2024;46:e-rbgo18. Parikshit Tank1
[Link]
DOI
[Link] Ketan Kulkarni13
[Link]

Onkar Swami13
[Link]

1
Ashwini Maternity and Surgical Hospital, Mumbai, India.
Keywords
Gupte Hospital and Centre for Research in Reproduction, Pune - Obstetrics and Gynecology, Pune, Maharashtra, India.
2
Comorbid conditions; Concomitant
medications; Dydrogesterone;
3
Prachee Nursing Home, Cuttack, India.
Gynecological conditions; Indian women;
4
J. J. Hospital, Hyderabad, Hyderabad, India.
Risk factors; Threatened abortion; 5
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Utilization pattern 6
CSS College of Obstetrics, Gynae. & Child health, Kolkata, India.
7
Vyas Clinic, Jaipur, Rajasthan Jaipur, India.
Submitted 8
Pushpam Hospital, Ahmedabad, India.
March 12, 2023
9
IVF and Endoscopy Centre, Ruby Hall Clinic, Pune, India.
Accepted 10
Rajendra Nagar Hospital and IVF Center, Lucknow, India.
July 24, 2023 11
Radhakrishna Multispecialty Hospital, Bangalore, Karnataka, India .
12
Bapat Hospital, Indore, Madhya Pradesh, India, Indore, India.
Corresponding author 13
Emcure Pharmaceuticals, Pune, Maharashtra, India.
Onkar Swami
E-mail: [Link]@[Link] Conflicts to interest: none to declare.

Associate Editor
Rogério Bonassi Machado Abstract
([Link]
Faculdade de Medicina de Jundiaí,
Objective: Despite the literature on dydrogesterone, studies on dydrogesterone utilization patterns
Jundiaí, SP, Brazil are largely lacking in Indian patients.

Rev Bras Ginecol Obstet. 2024;46:e-rbgo18. 1

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

Methods: This was a multi-center, retrospective, observational, cross-sectional, and descriptive

study across 817 centers in India. Data of patients who received dydrogesterone in past and provided
consent for future use of their medical record for research purpose was were retrieved and analyzed.
Results: Data of 7287 subjects (aged 29.55±4.84 years) was analyzed. Threatened abortion was
the most common indication for which the subjects received dydrogesterone (46.9%) followed by
recurrent pregnancy loss. Polycystic ovary syndrome (PCOS), thyroid disorders and anemia were the
most common comorbid conditions and prior pregnancy loss, advanced maternal age and obesity
were the most common risk factors seen in subjects who received dydrogesterone. Total 27.5% of
subjects received a loading dose of dydrogesterone, and majority (64%) received 40 mg as loading
dose. 10 mg dose was used as maintenance or regular dose in 81.4% of the subjects. Twice daily (BID)
was the most common dosing frequency (66.6%). The most common concomitant medications
being taken by the subjects on dydrogesterone included folic acid (45.1%), iron supplements (30.3%)
and calcium and vitamin D3 supplements (25.5%). Another progesterone preparation (oral, injection,
vaginal, tubal) other than dydrogesterone was used concurrently in 7.8% of subjects.
Conclusion: The study helped to identify the patient population that is benefitted by dydrogesterone
and the preferred indications, risk factors, comorbid conditions and concomitant medication used
in this patient population at real-life scenario.

Introduction fertilization (IVF) cycles and for treating threatened mis-

Progesterone has an important place in the management carriages due to corpus luteum insufficiency.(10-12) The use of
of obstetric and gynecological conditions.(1-3) Progesterone dydrogesterone has been correlated with higher pregnancy
can be given orally, intramuscularly, subcutaneously, intra- rate and live birth rate than with micronized progesterone in
vaginally and through rectal routes.(4) Of these, oral route is patients requiring luteal phase support during IVF.(4)
most convenient for patients.(4) However, oral micronized Despite the extensive literature on dydrogesterone,
progesterone has limited use in clinical practice because studies on dydrogesterone utilization patterns are largely
it undergoes extensive first-pass metabolism and therefore lacking in Indian patients. Therefore, the present study was
has relatively low bioavailability.(4) conducted with objective of assessing the dydrogesterone
Dydrogesterone is a stereoisomer of progesterone that utilization patterns in various obstetric and gynecological
is pharmacologically close to endogenous progesterone.(1,5) conditions in Indian women at real life scenario. The study
It has high oral bioavailability, is more specific for progester- also aimed to identify the frequencies of risk factors and
one receptors than micronized progesterone, and therefore co-morbidities in patients receiving dydrogesterone and the
a 10–20 times lower oral dose than micronized progester- concomitant medications.
one is required to exert the pharmacological action.(1,4,5) The
androgenic, glucocorticoid, mineralcorticoid or estrogenic
side-effects of dydrogesterone are significantly less com- Methods
pared with micronized progesterone.(1,6) This was a multi-center, retrospective, observational,
Dydrogesterone has been in use for over 60 years, and cross-sectional, and descriptive study conducted across
has demonstrated a favorable efficacy, safety and tolera- 817 centers spanning major urban and rural regions of India.
bility profile across multiple obstetric and gynecological A case report form (CRF) was designed prior to the study
indications.(1,7-9) Dydrogesterone has been efficiently used and shared with the Obstetricians and Gynecologists across
for progesterone-deficient obstetrical conditions such as India. Each center was given 10 CRFs. data was filled from
threatened abortion, recurrent pregnancy loss, infertility the medical records of women ≥ 18 years of age who received
due to luteal phase deficit, and gynecological conditions dydrogesterone in the past as their standard of care (SOC)
such as endometriosis, dysfunctional uterine bleeding, for any obstetric or gynecologic condition.
secondary amenorrhea, irregular menstrual cycles and pre- The study subjects received oral dydrogesterone in a
menstrual syndrome.(1,4,7,10-19) Dydrogesterone is the most dosage considered appropriate by their physician for that
commonly prescribed progesterone during pregnancy and condition. The locally approved prescribing information for
for threatened abortion.(9,20) Oral dydrogesterone carries the dydrogesterone is provided in chart 1.(21)
least risk of miscarriage while treating threatened abortion The following data was retrieved from medical records
and recurrent pregnancy loss as compared to other proges- and filled in the CRFs: demographic details, comorbidities,
terone.(7,13) risk factors, indication, dose, dosing frequency, regimen and
It has been found to be as effective as micronized duration of treatment of dydrogesterone in various obstetric
progesterone for luteal phase support during in-vitro and gynecological conditions and concomitant treatment

2 Rev Bras Ginecol Obstet. 2024;46:e-rbgo18.

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

Chart 1. Dydrogesterone prescribing information Table 1. Demographic profile of study subjects

Indication Dose n MEAN±SD MEDIAN (IQR) RANGE (Min-Max)
Threatened An initial loading dose of up to 40 mg may be given followed by Age (year) 7108 29.55±4.84 29(26,32) 18 to 45
abortion 20 or 30 mg per day until symptoms remit Weight (kg) 7062 59.38±9.35 59(53,65) 38 to 113
Recurrent 10 mg BID until the twentieth week of pregnancy Height (cm) 7072 156.79±7.2 156(152,161) 136 to 179
pregnancy loss BMI (KG/m2) 7013 24.23±3.84 23.83(21.76,26.11) 12.91 to 47.11
Infertility due to 10 or 20 mg daily starting with the second half of the menstrual Gravida 3770 - 2(1,3) 0 to 10
luteal insufficiency cycle until the first day of the next cycle for three consecutive
Para 3265 - 0(0,1) 0 to 6
cycles
Abortions 3273 - 1(0,1) 0 to 7
Endometriosis 10 to 30 mg daily from day 5 to day 25 of the cycle or continuously
Living offsprings 2712 - 0(0,1) 0 to 3
Irregular cycles 10 or 20 mg daily starting with the second half of the menstrual
cycle until the first day of the next cycle
Pre-menstrual 10 mg daily starting with the second half of the menstrual cycle
syndrome until the first day of the next cycle
Dysfunctional When treatment is started to arrest a bleeding episode, 20 or Results
uterine bleeding 30 mg dydrogesterone per day is to be given for up to 10 days. Baseline characteristics
For continuous treatment, 10 or 20 mg dydrogesterone per day
should be given during the second half of the menstrual cycle.
Data of 7287 subjects (aged 29.55±4.84 years) who had re-
Secondary 10 or 20 mg dydrogesterone per day, to be given daily for 14 ceived dydrogesterone as part of their SOC were included
amenorrhea days during the second half of the theoretical menstrual in the study; Demographic details of the subjects, and their
cycle to produce an optimum secretory transformation of an
endometrium that has been adequately primed with either obstetric history are captured in (Table 1). Of the subjects,
endogenous or exogenous estrogen 83.3% were pregnant. A total of 73.8% of subjects had a pre-
Hormone - Continuous sequential therapy: An estrogen is dosed
vious pregnancy loss, and 43.2% of these had experienced
replacement continuously and one tablet of 10 mg dydrogesterone is added
therapy for the last 14 days of every 28 day cycle, in a sequential manner. early pregnancy bleeding during the previous miscarriage.
- Cyclic therapy: When an estrogen is dosed cyclically with a
Other causes of previous pregnancy loss are depicted in
treatment-free interval, usually 21 days on and 7 days off. One
tablet of 10 mg dydrogesterone is added for the last 12 -14 days of (Figure 1).
estrogen therapy.
- Depending on the clinical response, the dosage can
subsequently be adjusted to 20 mg dydrogesterone per day. Frequency of comorbid conditions in subjects
receiving dydrogesterone
Polycystic ovary syndrome (PCOS) and thyroid disorders
used along with the dydrogesterone. All the data from the were the most common comorbid conditions identified in
817 centers was received at a central facility of the Sponsor, 23% and 21% of subjects, respectively. Other comorbid con-
checked for inconsistencies, and entered in Microsoft Excel ditions identified (Table 2) were anemia and hypertension
sheet. The data was analyzed using descriptive statistical in 19.9% and 13.3% of subjects, respectively. PCOS (24.7% and
methods. Categorical data was represented as frequencies 21%), thyroid disorders (24.7% and 24%) and anemia (19.9%
and percentages, while quantitative data was described as and 25%) were the most common comorbid conditions seen
mean ± standard deviation (SD) or median with interquar- in subjects who received dydrogesterone for threatened
tile range (IQR) as appropriate. Given the retrospective na- abortion and recurrent pregnancy loss, respectively. PCOS
ture of the study, informed constent could not be taken from was the most common comorbid condition in subjects with
the patients whose data was collected from the medical re- threatened abortion and anemia was the most common
cords. However, the study was conducted according to the comorbid conditions in subjects with recurrent pregnancy
Principles of Helsinki. Further, this study was approved by loss. Other comorbid conditions seen in subjects with these
the Deccan Independent Ethics Committee. two conditions are depicted in (Figure 2).

1.6%
Ectopic pregnancy
119

2.7%
Still Birth
198

7.2%
Preterm Birth
524

19.1%
History of two or more miscarriages
1394

43.2%
Early pregnancy bleeding
3146

0 500 1000 1500 2000 2500 3000 3500

Percentage Number

Figure 1. Causes of previous pregnancy loss

Rev Bras Ginecol Obstet. 2024;46:e-rbgo18. 3

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

Table 2. Risk factors and comorbid conditions identified in subjects

prescribed dydrogesterone
Dydrogesterone utilization pattern
n=7287 n(%)
Indications for dydrogesterone use
Risk factors Dydrogesterone was most commonly prescribed for obstre-
Prior pregnancy loss 1981(27.2) trical conditions. Threatened abortion was the most com-
Advanced maternal age 1397(19.2)
mon indication for which the subjects received dydroges-
Obesity 1177(16.2)
Family History 761(10.4)
terone (46.9%) followed by recurrent pregnancy loss (27.3%).
Advanced paternal age 356(4.9) Dydrohesterone was also prescribed for several gynecolog-
Associated medical condition 322(4.4) ical conditions. The most common gynecological condition
Alcohol Consumption 176(2.4)
for which subjects received dydrogesterone was infertility
Defects in the uterine and fallopian tube 175(2.4)
Smoking 164(2.3)
due to luteal phase insufficiency. Other gynecological indi-
Comorbid conditions cations for which the subjects received dydrogesterone are
PCOS 1678(23) mentioned in (Table 3).
Thyroid Disorder 1528(21)
Anaemia 1448(19.9)
Hypertension 971(13.3)
Dosage, dosing and regime
Diabetes 545(7.5) Slightly more than one quarter of the subjects (27.5%) received
Uterine fibroids 287(3.9) a loading dose of dydrogesterone (n=2007/7287). Of the sub-
Dyslipidaemia 191(2.6)
jects who received a loading dose, majority (64%) received 40
Pre-eclampsia 141(1.9)
Thrombophilia 138(1.9)
mg as loading dose (Table 3). The proportion of patients who
Autoimmune disorder 132(1.8) received dydrogesterone loading dose for different indications
Hyperprolactinemia 95(1.3) are depicted in (Figure 4). Threatened abortion was the most
common indication for which a loading dose was used. Most of
the subjects (81.4%) received a 10 mg across indications either
Frequency of risk factors identified in subjects as maintenance dose or a regular dose (Table 3). Twice daily
receiving dydrogesterone (BID) was the most common dosing frequency (66.6%).
Prior pregnancy loss was the most common risk factor iden-
tified in 27.2% of subjects who received dydrogesterone. Concomitant medications received by subjects
Other risk factors identified (Table 2) were advanced ma- along with dydrogesterone
ternal age (19.2%) and obesity (16.2%). Prior pregnancy loss The most common concomitant medications being taken
(27.4% and 44.2%), advanced maternal age (20.7% and 19.8%) by the subjects on along with dydrogesterone included fol-
and obesity (15.5% and 19.7%) were the most common risk ic acid (45.1%), iron supplements (30.3%) and calcium and
factors seen in subjects who received dydrogesterone for vitamin D3 supplements (25.5%). Concomitant medications
threatened abortion and recurrent pregnancy loss, respec- received by the subjects are captured in (Table 4). Another
tively. Other risk factors seen in subjects with these two con- progesterone preparation (oral, injection, vaginal) other
ditions are depicted in (Figure 3). than dydrogesterone was used in 7.8% of subjects.

1.70%
Hyperprolactinemia
1.20%
1.60%
Autoimmune disorder
1.50%
1.50%
Thrombophilia
1.50%
2.60%
Pre-eclampsia
2%
2.10%
Dyslipidaemia
2.20%
7.50%
Uterine fibroids
4.10%
10%
Diabetes
7.10%
12%
Hypertension
14%
25%
Anemia
19.90%
21%
PCOS
24.70%
24%
Thyroid disorder
24.70%

0% 5% 10% 15% 20% 25%

Recurrent pregnancy loss (N=1,986) Threatened abortion (N=3,421)

Figure 2. Common comorbidities in subjects with threatened abortion and recurrent pregnancy loss

4 Rev Bras Ginecol Obstet. 2024;46:e-rbgo18.

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

Defects in the uterine and fallopian tube 1.90%

2.10%

Alcohol consumption 4.10%

2.30%
Smoking
2.60%
2.50%
Associated medical condition
2.80%
Advanced paternal age 4.20%

8.20%
Family history
4.90%

Obesity 11.30%
12.50%
Advanced maternal age
19.70%
15.50%
Prior pregnancy loss
19.80%
20.70%

44.20%
27.40%

0 10 20 30 40 50
Recurrent pregnancy loss (N=1,986) Threatened abortion (N=3,421)

Figure 3. Common risk factors in subjects with threatened abortion and recurrent pregnancy loss

Table 3. Dydrogesterone utilization pattern: indications, frequency,

dosage, dosing regime (timing) 40
40

Indications for dydrogesterone

35
n=7287 n(%)
30 28.6
Obstetric conditions
Threatened abortion 3421(46.9) 25 24.1
22.4
Recurrent pregnancy loss 1986(27.3) 20
16.2
Gynecological causes 14.9
15
Infertility due to luteal phase insufficiency 843(11.6)
10
Luteal phase support as a part of ART treatment 750(10.3)
Dysfunctional uterine bleeding 235(3.2) 5
2.5
4.1

Endometriosis 208(2.9) 0
Threatned Recurrent Infertility due Luteal phase Dysfunctional Endometriosis Secondary Hormone
Secondary Amenorrhea 79(1.1) abortion pregnancy to luteal support as a uterine amenorrhea replacement
loss phase part of ART bleeding therapy
Hormone replacement therapy 74(1) insufficiency treatment

Loading dose, dosing frequency, dosing regime (timing)

n=7287 n(%)
Loading dose prescribed 2007(27.5) Figure 4. Proportion of cases by indication who received dydroges-
No loading dose prescribed 5280(72.5) terone loading dose
Loading dose prescribed (n=2007)
20 mg 387(19.3)
30 mg 318(15.8) Table 4. Co-prescription medications for subjects prescribed dy-
40 mg 1285(64.0) drogesterone
50 mg 3(0.1)% Generic name/class of medication n(%)
60 mg 13(0.6)% Folic acid 3284(45.1)
80 mg 1(0.0)% Iron 2207(30.3)
Maintenance dose/starting without loading dose (n=5280) Calcium ± Vitamin D3 and supplements 1855(25.5)
10 mg 4299(81.4) Other vitamins and multivitamins/antioxidants 808(11.1)
20 mg 770(14.6) Protein powder 211(2.9)
30 mg 134(2.5) Thyroid medication 1000(13.7)
40 mg 72(1.4) Glucose lowering agents 788(10.8)
50 mg 4(0.08) Antihypertensive 98(1.3)
60 mg 1(0.02) Progesterone (oral, injection, vaginal, tubal; other than 569(7.8)
Dosing frequency (n=6851) dydrogesterone)
OD 869(12.7) Estrogen 52(0.7)
BID 4562(66.6) HCG 372(5.1)
TID 1420(20.7) Myo-inositol (n=11) and other unspecified medications for 130(1.8)
Dosing regimen (n=7286) PCOS related infertility, irregular menstruation
Morning 5744(78.8) Unspecified medications for hyperprolactinemia 90(1.2)
Afternoon 1381(19) Antacids and Anti-acidity 162(2.2)
Evening 5706(78.3) Medications to control uterine bleeding (Tranexamic acid) 41(0.6)
Cyclical/continuous (n=4791) Antinausea and vomiting in pregnancy 163(2.2)
Cyclical Treatment 1072(22.4) Aspirin 340(4.7)
Continuous Treatment 3719(77.6) Heparin 77(1.1)

Rev Bras Ginecol Obstet. 2024;46:e-rbgo18. 5

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

Discussion subjects who routinely received dydrogesterone as part of the

Progesterone plays a significant role in the maintenance SOC for their obstetric or gynecological conditions.
of a normal menstrual cycle and healthy pregnancy and This study reported that threatened abortion and re-
management of threatened abortion, recurrent pregnancy current pregnancy loss were the most common indications
loss (sequential loss of ≥3 pre-viable pregnancies)(22) and for which dydrogesterone was used, followed by recurrent
many other obstetrical and gynecological conditions.(4,23) pregnancy loss, infertility due to luteal phase insufficiency
Progesterone is a key management strategy for providing and luteal phase support as a part of ART. However, there
luteal support during IVF and assisted reproductive tech- was great variation in the use of the loading dose, dydroges-
nology (ART).(4) terone dosage, dosing frequency, regimen, and duration of
Progesterone can be administered through several dydrogesterone across indications.
routes such as oral, intramuscular and vaginal.(4) Micronized The study showed that prior pregnancy loss (27.2%),
vaginal progesterone (MVP) capsules can be self-adminis- advanced maternal age (19.2) and obesity (16.2%) were the
tered, and this is a commonly prescribed, effective and safe most common risk factors observed in patients who re-
method of administering progesterone. However, MVP can ceived dydrogesterone. These are also the most common
cause discomfort due to vaginal irritation and discharge, risk factors identified for threatened and recurrent pregnan-
and may not be culturally acceptable by some women.(4) cy loss, which were the most common indications for which
Oral route of drug administration is the most convenient subjects received dydrogesterone in this study.(27) It is im-
route for patients.(4) Oral progesterone can be prescribed as mi- portant to note that all other risk factors identified (family
cronized progesterone and as dydrogesterone. The Lotus I and history, advanced paternal age, associated medical condi-
II trials showed that oral dydrogesterone can be an effective tion, alcohol consumption, defects in the uterine and fallo-
and safe option to MYP.(4,24) On the other hand, oral micronized pian tube and smoking) have been associated with any kind
progesterone has limited use in clinical practice because it of abortion(27) and infertility,(28) the two major indications for
undergoes extensive first-pass metabolism and therefore has prescribing dydrogesterone.
low bioavailability.(4) Further, literaure shows that compared to Most of the subjects in this study had a pregnancy com-
other progesterones, oral micronized progesterone use was as- plicated by threatened abortion or recurrent pregnancy loss or
sociated with the highest risk of miscarriage.(13) needed luteal phase support for ART/continuation of pregnan-
A large cross-sectional study from China (N= 91,464) as- cy. In this subject population, PCOS, thyroid disorder, anemia
sessing drug utilization patterns in patients with threatened and hypertension were the most commonly observed comor-
abortion noted that dydrogesterone prescription rates increased bidities in the subjects of this study. Similar complications
over time from 2014 to 2020 while those of other progesterone were also noted by a large birth cohort study, which reported
preparations decreased over time.(20) Dydrogesterone has be- maternal hypertension, diabetes, thyroid disorders, obesity,
come the preferred treatment option in progesterone-deficient asthma, and tobacco use as the most common comorbidities
obstetric and gynecological conditions due to ease of adminis- in women prior to and during pregnancy.(29)
tering an oral dose, similar or better efficacy and tolerability than A loading dydrogesterone dose of 40 mg is usually given
micronized progesterone, lower dose due to high bioavailability, for threatened abortion.(21) However, almost half the subjects
and improved outcomes in infertility, threatened abortion and (48%) with threatened abortion did not receive a loading dose
recurrent pregnancy loss.(1,4,5,7,10-13) as per the local prescribing information (Chart 1).(21) Similarly,
Dydrogesterone has been in use for over 60 years with though 40 mg was the most prescribed loading dose (64%),
proven efficacy, safety and tolerability profile across multi- lower loading doses of 20 mg and 30 mg were also used in
ple obstetrical and gynecological indications.(1,7) Many large 19.3% and 15.8% of cases, respectively. Also, loading dose was
studies with threatened abortion (drug utilization study; used for conditions not requiring it as per the local prescrib-
China; N= 91,464), recurrent pregnancy loss (systematic re- ing information such as recurrent pregnancy loss (24%) and
view; N=509), for luteal support in IVF (dydrogesterone twice infertility due to luteal phase insufficiency (12%).
daily vs. micronized vaginal progesterone gel vs. oral micron- As per the local prescribing information, dydrogesterone
ized capsules; India; N=1,373) or ART (dydrogesterone plus maintenance dose of 20 or 30 mg per day should be prescribed
micronized vaginal progesterone gel vs. placebo plus micron- for threatened abortion, while 10 mg to 20 mg should be used
ized vaginal progesterone gel; India; N=498) show that dydro- across indications that do not require a loading dose (Chart 1).
gesterone is the most commonly used and effective and safe However, this study showed that majority of subjects (81.4%)
progesterone in these indications.(7,9,20,25,26) However, there are across indications were on 10 mg dose, used as a maintenance
no studies on the utilization pattern of dydrogesterone across or as continuous/cyclic dose without a loading dose. However,
various obstetric and gynecological conditions in Indian pop- since BID was the most common dosing frequency (66.6%),
ulation. This is a large Indian study, that to best of our knowl- many patients on 10 mg dose received 20 mg daily, which is in
edge, shows the dydrogesterone utilization patterns in 7287 line with the prescribing information.

6 Rev Bras Ginecol Obstet. 2024;46:e-rbgo18.

 Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study
Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay AK, et al

The study showed that continuous dosing was pre- factors and comorbid conditions, and the common concom-
scribed in most cases (77.6%). However, dydrogesterone itant medications used in this patient population at real-life
should be prescribed in cyclic dosing for most indications scenario.
(Chart 1) except in endometriosis and dysfunctional uterine
bleeding (DUB) and as continuous sequential therapy with
estrogen in hormone replacement therapy (HRT). Acknowledgements
The most common concomitant medications being The authors thank Ms. Rutuja Tope for data management;
taken by the subjects on dydrogesterone in this study in- Dr. Srikant N for statistical analysis; Mr. Rajeev Agarwal,
cluded folic acid (45.1%), iron supplements (30.3%) and Mr. Unmesh Birje, Mr. Kekunnaya Krishna Prasad, and Mr.
calcium and vitamin D3 supplements (25.5%). This is the Raghavendra Reddy for administrative support; and Dr. Punit
first study elaborating the concomitant medication used in Srivastava, and Dr. Kokil Mathur of Mediception Science Pvt.
different obstetrical and gynecological conditions in Indian Ltd ([Link]) for providing medical writing
women who received dydrogesterone. support in the preparation of this manuscript.
This study also showed that 7.8% of patients were pre-
scribed multiple progesterone preparations across indi-
cations. The cross-sectional study from China too reported Author’s contributions
that 12% of patients used multiple progesterone prepara- Tank J, Gupte S, Mahapatra PC, Reddy J, Mittal P, Mukhopadhyay
tions for threatened abortion. Of these, dydrogesterone AK, Vyas L, Batra A, Gupta M, Tandulwadkar S, Chandra S, Bhat
combinations with injectable and oral progesterones were V, Tank P, Kulkarni K and Swami O contributed to the design
used by 5.6% and 1.1% of patients, respectively. Combination of the study, were involved in the data collection, data analy-
of oral dydrogesterone with another progesterone for luteal sis and/or interpretation. Also, all authors contributed to the
support during ART has been found to reduce miscarriage writing/substantive editing and review of the manuscript and
and improve live birth rate.(30,31) approved the final draft of the manuscript.
The study is limited by its retrospective design and the
fact that the accuracy of the data collected depended on the
physicians. Further, the study had no control on the indica- References
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