A study to examine the effect of Dydrogesterone Sustained Release Tablets 30 mg for the treatment of endometriosis associated pain in women.

Phase 3

Completed

• Conditions: Health Condition 1: N809- Endometriosis, unspecified

• Registration Number: CTRI/2023/03/050791
• Lead Sponsor: Ravenbhel Healthcare Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-10-11
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified