Phase II study to evaluate pharmacodynamics, pharmacokinetics and safety after cyclic dose or continuous dose of FSN-013 for 3 cycles in Japanese healthy adult female subjects
- Conditions
- dysmenorrhea
- Registration Number
- JPRN-jRCT2080223983
- Lead Sponsor
- Fuji Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 60
(1) Japanese Healthy adult female subjects (subjects who were judged to be healthy by investigators)
(2) 20 or older and younger than 35 years old
(3) Subjects whose weights were 40 kg or more and BMIs were18.5 or more and less than 25.0 at screening examinations
(4) Subjects who ovulated between Day9(+/-1) and Day 27(+/-1) of their menstruations in pretreatment observation period and whose progesterone concentrations after that were 5 ng/mL or more and menorrhea didn't start before second registration.
(5) Subjects whose both ovaries can be observed by transvaginal ultrasound examinations.
(1) Subjects whose menstrual cycles were beyond range of 25 to 38 days regularly
(2) Subjects whose spontaneous menorrhea were not observed previously after dosing hormonal products for contraception
(3) Subjects in whom unknown cause of abnormal bleedings were observed within past 6 months or their reoccurences were expected during tiral period
(4) Subjects whose cervix cytodiagnoses were abnormal previously
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacodynamics<br>Ovulation inhibition assessed by Hoogland score in 1st and 3rd cycles
- Secondary Outcome Measures
Name Time Method safety<br>exploratory<br>pharmacodynamics<br>Blood levels of FSH, LH, endogenous estrogen, endogenous progesterone, thickness of endometrium