| CTRI Number |
CTRI/2026/01/100704 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Dydrogesterone Tablets for Supporting Pregnancy in Women with Habitual Miscarriages. |
|
Scientific Title of Study
|
A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Dydrogesterone Extended-Release Tablets 20 mg in pregnant women with habitual miscarriages. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C2B05785; Version: 01, Dated 06May25 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ms. Swati Sharma |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India.
Phone:07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9650035772 |
| Fax |
|
| Email |
sgsharma@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Mori |
| Designation |
Medical Monitor |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India. Phone:07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavankumar Daultani |
| Designation |
General Manager – Clinical R&D |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Research Centre, Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A, Moraiya, Ahmedabad – 382213, Gujarat, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
8511697284 |
| Fax |
|
| Email |
Pavankumar.daultani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway Ahmedabad- 382481, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Zydus Healthcare Limited |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway Ahmedabad- 382481, Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sweta Singh |
All India Institute of Medical Sciences |
Sijua, Patrapada, Bhubaneswar – 751019, Odisha
Khordha
ORISSA |
9438884131
obgyn_sweta@aiimsbhubaneswar.edu.in |
| Dr Deepthi Bawa |
Citizen Hospital |
14, 2nd main, Dispensary Road, Kalavipalya, Bangalore, Karnataka - 560002
Bangalore
KARNATAKA |
9880996866
deepthibawa@gmail.com |
| Dr Yamini Trivedi |
Sheth L.G. General Hospital |
Department of Obstetrics and Gynecology,Near Rambaug, Maninagar, Ahmedabad-380008
Ahmadabad
GUJARAT |
9825170542
yamilesh2@gmail.com |
| Dr Pratibha Singh |
Tender Palm Hospital |
Sector-7, Gomti Nagar Extension, Amar Shaheed Path, Lucknow – 226010, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
8874260674
drpratibhakgmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Citizen Hospital Institutional Ethics committee |
Approved |
| Independent Ethics Committee Narayana Diagnostic |
Approved |
| Institutional Ethics committee |
Approved |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dydrogesterone Extended-Release tablets (Dydrogest-ER 20) |
One tablet to be consumed orally, once daily along with water.
Consumption of tablet until the 20th gestational week.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant woman aged 20 to 39 years (both inclusive at the time of screening).
2) Participants with unexplained recurrent miscarriages (based on a documented history of 2 or more spontaneous, consecutive miscarriages before 20 weeks gestation) with same partner.
3) Spontaneous conception (as confirmed by serum pregnancy test).
4) Presence of a viable pregnancy with gestational age of 5 to 8 weeks at the time of screening.
5) Positive urine pregnancy test within 2 weeks prior to screening (based on participant’s confirmation).
6) Body mass index (BMI) in the range of 18.5 to 29.9 kg/m2 (both inclusive).
7) Participants who are literate and with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
8) Participants who are willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Participants with known hypersensitivity to dydrogesterone.
2) Participants who may have structural uterine anomalies like septate uterus, bicornuate uterus, fibroid, Asherman’s syndrome as assessed by Ultrasonography.
3) Participants with vaginal bleeding or severe abdominal pain requiring surgical intervention.
4) Participants with other clinically significant causes of miscarriage (endocrine disorders) identified during examination (including but not limited to pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, PCOS, hyperprolactinemia).
5) Participants with evidence of clinically relevant cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunologic, dermatologic, connective tissue, Musculo-skeletal, neurologic, psychiatric disorders, major surgery or other relevant disease as revealed by history, physical examination and/or laboratory assessments which might limit participation in, or completion of, the study.
6) Participants with presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat.
7) Participants with evidence of ectopic pregnancy
8) Participants with evidence of multiple pregnancy.
9) Participants with anembryonic pregnancy or fetal malformations as established causes of loss of previous pregnancies - conceived on gonadotrophins or with the use of assisted reproductive technologies.
10) Participants with uterine myoma with submucosal location of the node (a clinically significant size as judged by the Investigator).
11) Participants with known or suspected progesterone dependent neoplasms
12) Participants with Sexually Transmitted Diseases (STDs)
13) Participants with an endocervical polyp.
14) Participants with autoimmune diseases such as but not limited to systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis.
15) Participants with coagulation disorder.
16) Participants with history of chemotherapy or radiotherapy.
17) Use of dydrogesterone or progesterone or hCG within 30 days prior to screening.
18) Participants with current or ongoing substance abuse, including alcohol and tobacco.
19) Participants with suspected inability or unwillingness to comply with the study procedures.
20) Participation in any other clinical trial within 30 days prior to screening.
21) Planned participation in any other trial during the entire duration of the study.
22) Participant with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing participant’s safety and her inability to understand and comply with the requirements of the surveillance.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with ongoing pregnancy at 20 weeks |
Visit 02 {Week 5 to 8 of gestation} up to end of study i.e., Visit 04 {Week 20 of gestation} |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with ongoing pregnancy at 12 weeks |
Visit 02 {Week 5 to 8 of gestation} up to Visit 03 {Week 12 of gestation} |
| Miscarriage rate |
Visit 02 {Week 5 to 8 of gestation} up to end of study i.e., Visit 04 {Week 20 of gestation} |
| Monitoring adverse events (AEs) and Serious adverse events (SAEs) |
Throughout the study duration |
| Monitoring vital signs and conducting physical examination |
At each study visit |
| Monitoring change in Hematological parameters, Routine Biochemical parameters and Routine Urinalysis |
Screening Visit (Visit 01) and Visit 04 (Week 20 of gestation) |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open label, single-arm, multicentre, phase IV clinical trial
to assess efficacy and safety of Dydrogesterone Extended-Release Tablets 20 mg
in pregnant women with habitual miscarriages.
The potential participants will be screened as
per the inclusion and exclusion criteria only after obtaining their written
informed consent.
The expected study duration will be
approximately 12-15 weeks and will comprise of 04 study visits. - Visit 01: Screening Visit (Upto Day -3) - Visit 02: Enrolment Visit (Day 01 / Week 5 to 8
of gestation) and Start of Treatment - Visit 03: Evaluation Visit (Week 12 of
gestation) - Visit 04: Evaluation Visit (Week 20 of
gestation) and End of Study |