An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patients
Phase 2
Completed
- Conditions
- endometriosis
- Registration Number
- JPRN-jRCT2080225090
- Lead Sponsor
- Fuji Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
1. Japanese patients, diagnosed as endometriosis by laparotomy/laparoscopy, and/or as having ovarian chocolate cysts by TVUS or MRI
2. Aged >= 20 and < 50 years
3.BMI < 30 kg/m2
Exclusion Criteria
1. Undiagnosed abnormal vaginal bleeding 6 months before the screening tests
2. Aged >= 40 years with ovarian chocolate cyst for which the largest diameter was > 10 cm
3. Ovarian chocolate cyst containing solid components
4. Had undergone surgical treatment for endometriosis by cyst puncture (such as transvaginal alcohol fixation), laparotomy, or laparoscopy (laparoscopy) within 2 months prior to the screening tests
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method