To study efficacy and safety of Progesterone SR tablets in patient with secondary amenorrhea
- Conditions
- Health Condition 1: null- Women with secondary amenorrhea associated with normal estrogen levels
- Registration Number
- CTRI/2016/11/007433
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 388
1.Non hysterectomized women of the age of 25 to 45 years.
2.Women whose menstrual cycles disappear for 6 consecutive months with irregular menses or for 3 consecutive months with regular menses
3.Women willing to give informed consent
1.Women with hypersensitivity to any of the test or control formulation drugs or their excipients
2.Pregnant or nursing women
3.Women of childbearing potential not using medically approved means of contraception
4.History of drug or alcohol abuse
5.Women who are in menopause phase
6.Women with undiagnosed irregular vaginal bleeding
7.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy will be excluded from the study
8.Women with malignancy (uterine breast) or with family history of malignancy
9.Women with gall stone disease
10.Women with DVT or history of CVD
11.Women with thyroid disease
12.Women with ovarian failure
13.Women with Ashermans Syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Inducing withdrawal bleeding <br/ ><br>2.maintaining regular <br/ ><br>bleeding, in women with secondary amenorrheaTimepoint: At day 0 <br/ ><br>At day 30 <br/ ><br>At day 60 <br/ ><br>At day 90
- Secondary Outcome Measures
Name Time Method 1.Tolerability <br/ ><br>2.Changes in bleeding pattern post treatment as compared to baselineTimepoint: At day 0 <br/ ><br>At day 30 <br/ ><br>At day 60 <br/ ><br>At day 90