dysmenorrhea
Conditions
Sponsors
Fuji Pharma Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacodynamics Ovulation inhibition assessed by Hoogland score in 1st and 3rd cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| safety exploratory pharmacodynamics Blood levels of FSH, LH, endogenous estrogen, endogenous progesterone, thickness of endometrium | — |
Countries
Japan
Outcome results
None listed