JPRN-jRCT2080223983
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fuji Pharma Co., Ltd.
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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