CTRI/2023/06/053743 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On:
08/11/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to examine the effect of Dydrogesterone Extended Release Tablets 30 mg for the treatment of endometriosis associated pain in women.
Scientific Title of Study
A prospective, randomized, double-blind, single-dummy, two-arm, active-controlled, parallel, multicentre, phase III clinical trial to assess the efficacy & safety of Dydrogesterone Extended Release Tablets 30mg as compared to Dydrogesterone Tablets 10mg for treatment of endometriosis in women.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Project No.: 23-02, Version No.: 00 and Dated Feb 24, 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ravindra Mittal
Designation
Medical Advisor and Head - Regulatory Affairs
Affiliation
Zydus Healthcare Limited
Address
Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad.
Ahmadabad GUJARAT 382481 India
Phone
079-48041430
Fax
079-48041500
Email
r.mittal@zyduslife.com
Details of Contact Person Scientific Query
Name
Dr Pavankumar M Daultani
Designation
Deputy General Manager - New Product Development
Affiliation
Zydus Healthcare Limited
Address
Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad.
Ahmadabad GUJARAT 382481 India
Phone
079-48041435
Fax
079-48041500
Email
pavankumar.daultani@zyduslife.com
Details of Contact Person Public Query
Name
Dr Pavankumar M Daultani
Designation
Deputy General Manager - New Product Development
Affiliation
Zydus Healthcare Limited
Address
Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad.
GUJARAT 382481 India
Phone
079-48041435
Fax
079-48041500
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, Sarkhej-Gandhinagar Highway, Ahmedabad-382481,
Gujarat, India.
Primary Sponsor
Name
Zydus Healthcare Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481,
Gujarat, India.
One Dydrogesterone Extended Release Tablet 30mg in morning and one matching placebo in the afternoon and night at about the same time daily continuously for 90 days starting from the day of randomization. Thus, each subject will be required to take 3 tablets daily (one in morning, one in afternoon and one in the night).
Comparator Agent
Dydrogesterone Tablets 10mg
Three tablets of Dydrogesterone Tablets 10mg (once in morning, one in afternoon and one in night at about the same time daily) continuously for 90 days starting from the day of randomization. Thus, each subject will be required to take 3 tablets daily (one in morning, one in afternoon and one in the night).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Female
Details
1. Female patients of age 18-45 years (both inclusive).
2. Patients diagnosed with endometriosis based on USG.
3. Patients with endometriosis associated pain score of at least 30mm on 100mm visual analog scale.
4. Patients willing to give written informed consent and comply with the study procedures.
ExclusionCriteria
Details
1. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception.
2. Patients who have achieved menopause or have premature ovarian insufficiency.
3. Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.
4. Patients with laparoscopic surgery for endometriosis within last 6 months.
5. Patients who have taken hormone therapy (danazol, progestins or other sex hormones, corticosteroids, GnRH analogs or gestrinone) in last 6 months or oral contraceptives in last 3 months.
6. Patients regularly using analgesics not intended to relieve endometriosis-related chronic pelvic pain (e.g. using analgesics for osteoarthritis etc).
7. Patients with any other significant concomitant gynecological disorder (fibroid etc).
8. Subjects with active or recent (within 6 months) arterial thromboembolic disease (e.g. angina, myocardial infarction) or venous thromboembolism (deep vein thrombosis, pulmonary embolism) or at high risk of venous or arterial thrombosis.
9. Subjects with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl).
10. Subjects with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine (diabetes), immunological or hematological disorders or malignancy.
11. Subjects with continuing history of alcohol and/or drug abuse.
12. Subjects with history of allergy to Dydrogesterone or other similar hormonal products.
13. Participation in another clinical trial in the past 3 months prior to screening.
14. Any other reason for which the investigator feels that patient should not participate.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change in Endometriosis Associated Pelvic Pain (EAPP) from baseline to end of study as assessed on 100mm VAS scale.
At Baseline / Visit 2 (Day 0),
At Visit 3 (Day 30),
At Visit 4 (Day 60) and
At Visit 5 (Day 90).
Secondary Outcome
Outcome
TimePoints
Consumption of rescue pain medication for endometriosis associated pelvic pain during the study period in the two groups.
At Visit 3 (Day 30),
At Visit 4 (Day 60) and
At Visit 5 (Day 90).
Change in size of Endometrioma from baseline to end of study as assessed
by USG.
At Screening / Visit 1 (Day -3) and
At Visit 5 (Day 90).
Change in serum VEGF levels from baseline to the end of the study in the two groups.
At Baseline / Visit 2 (Day 0) and
At Visit 5 (Day 90).
Changes from baseline in the health-related quality of life using the HRQoL-4 questionnaire in the two groups at the end of the study.
At Baseline / Visit 2 (Day 0),
At Visit 3 (Day 30),
At Visit 4 (Day 60) and
At Visit 5 (Day 90).
Adverse events / serious adverse events reported during the study.
At Baseline / Visit 2 (Day 0),
At Visit 3 (Day 30),
At Visit 4 (Day 60) and
At Visit 5 (Day 90).
Target Sample Size
Total Sample Size="228" Sample Size from India="228" Final Enrollment numbers achieved (Total)= "228" Final Enrollment numbers achieved (India)="228"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a
prospective, randomized, double-blind, single-dummy parallel, active controlled,
multicenter, non-inferiority, phase III clinical trial to assess the efficacy
and safety of Dydrogesterone Extended Release Tablets 30 mg as compared to Dydrogesterone
Tablets 10 mg for treatment of endometriosis in women. The test drug is
indicated for once daily dosing while the reference drug is indicated for
thrice daily dosing. Due to this difference in dosing of the test and the
reference drugs, a similar looking placebo will be used for the patients
enrolled in the test group to maintain double blinding. All the drugs i.e., the
test drug, the reference drug or the placebo will have identical physical
characteristics and will be indistinguishable from each other. Randomization
will prevent the selection / treatment allocation bias and double blinding will
prevent the bias in the assessment of treatment effects. Randomized patients will
be enrolled in either of the 2 study groups as per their randomization number
and will be followed up in a parallel manner till the completion of study.