CTRI/2023/03/050791 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On:
01/11/2023
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 Sustained Release Tablets 30 mg for the treatment of endometriosis associated pain in women.
Scientific Title of Study
“A Phase III, Randomized, Double Blind, Single Dummy, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Dydrogesterone Sustained Release Tablets 30 mg versus Dydrogesterone Tablets 10 mg for the Treatment of Endometriosis in Women.â€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT/2022/44, Version No.: 00 and Dated Dec 01, 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar, Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar, Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar, Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Source of Monetary or Material Support
Ravenbhel Healthcare Pvt. Ltd., 16-17, EPIP, SIDCO, Kartholi, Bari-Brahamana, Samba-181133, Jammu and Kashmir, India.
Primary Sponsor
Name
Ravenbhel Healthcare Pvt. Ltd.
Address
16-17, EPIP, SIDCO, Kartholi, Bari-Brahamana, Samba-181133, Jammu and Kashmir, India.
Patients will be advised to take one tablet thrice a day orally, swallowed with water in the morning, afternoon and evening around same time every day for 90 days.
Morning - One tablet of test product,
Afternoon - One tablet of placebo matching test product &
Evening - One tablet of placebo matching test product
Treatment Period: 90 Days
Comparator Agent
Dydrogesterone Tablets 10 mg
Patients will be advised to take one tablet thrice a day orally, swallowed with water in the morning, afternoon and evening around same time every day for 90 days.
Morning - One tablet of reference product,
Afternoon - One tablet of reference product &
Evening - One tablet of reference product
Treatment Period: 90 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Female
Details
1. Female patients of aged between 18-45 years (both inclusive).
2. Patients diagnosed with endometriosis based on imaging studies i.e., USG.
3. Patients with endometriosis associated pelvic pain having a score of at least 30 mm on a 100 mm visual analog scale.
4. Patients having agreed to the use of double barrier contraception (use of the male condom along with either diaphragm, cervical cap, or copper T IUD).
5. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with all the protocol requirements.
ExclusionCriteria
Details
1. Patients with intolerance, contraindication or potential allergy/hypersensitivity to Dydrogesterone.
2. Patients with laparoscopic surgery for endometriosis within 6 months before screening.
3. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
4. Females who are not ready to use acceptable contraceptive methods during study.
5. Patients with previous use of hormonal agents (e.g., GnRH agonists ≤ 6 months, Danazol ≤ 3 months or oral contraceptives ≤ 1 month before screening).
6. Patients who have achieved menopause or have premature ovarian insufficiency.
7. Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.
8. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety.
9. Patients with any other significant concomitant gynecological disorder (fibroid etc.).
10. Patients 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.
11. Patients regularly using analgesics not intended to relieve endometriosis associated chronic pelvic pain (e.g., using analgesics for osteoarthritis etc.).
12. Patients with hepatic dysfunction (SGOT & SGPT ≥ 3 X Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dL).
13. Patients with any abnormality detected on ECG at the time of screening.
14. Patients with history of drug or alcohol abuse.
15. Patients with medical history of oncological conditions.
16. Patients with known case of HIV, Hepatitis B & C.
17. Patients with concurrent participation in another clinical trial within 30 days prior to signing informed consent.
18. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
19. Patients with suspected inability or unwillingness to comply with the study procedures.
20. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
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
Mean change in endometriosis associated pelvic pain from baseline to end of the study, assessed by a visual analogue scale (VAS; 0 mm means absence of pain, 100 mm means unbearable pain).
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
trial is a phase III, randomized, double blind, single dummy, active
controlled, prospective, parallel group, comparative, multicentric clinical
study to evaluate the efficacy, safety and tolerability of Dydrogesterone
Sustained Release Tablets 30 mg versus Dydrogesterone Tablets 10 mg for the
treatment of endometriosis in women.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening visit (Visit 1). During this
screening period, patients who are willing to give consent will be evaluated
for all the eligibility criteria. Eligible patients (female) aged 18 to 45 years
(both inclusive), diagnosed with endometriosis based on imaging studies i.e.,
USG and endometriosis associated pelvic pain having a score of at least 30 mm
on a 100 mm visual analog scale at screening visit will be considered for the
study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on day 30(±3), day 60(±3) and day 90(±3) (final
visit) of treatment to assess efficacy, safety and tolerability.
Patients
will be assigned to either of the two arms i.e., Arm A or Arm B consisting of Dydrogesterone
Sustained Release Tablets 30 mg & Placebo Tablets or Dydrogesterone Tablets
10 mg.
Patients
will be advised to take one tablet thrice a day orally, swallowed with water in
the morning, afternoon and evening around same time every day for 90 days.