A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
Phase 3
Completed
- Conditions
- InfertilityAnovulation
- Interventions
- Drug: DA-3801 InjectionDrug: Gonal-F®
- Registration Number
- NCT01820728
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
open label, active-controlled, randomized, parallel group, comparative study.
- Detailed Description
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
Inclusion Criteria
- WHO group II
- Clomiphene citrate resistance
- BMI: 17~29 kg/m^2
- Irregular menstrual cycle
- Normal blood concentration of FSH, E2, prolactin and TSH
Exclusion Criteria
- Uncontrolled endocrine disease
- Ovarian cystic tumor which are NOT related to PCOS
- Severe endometriosis
- Chronic cardiovascular disease, liver complaint
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DA-3801 injection DA-3801 Injection Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days Gonal-F® Gonal-F® 75 IU/day is injected for 14 days
- Primary Outcome Measures
Name Time Method The ovulation rate after 3 cycles of the injection 5 weeks maximum
- Secondary Outcome Measures
Name Time Method Total dose used, IU (International Unit) 5 weeks Threshold dose, IU 5 weeks Number of follicles 5 weeks Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Duration of stimulation, days 5 weeks
Trial Locations
- Locations (1)
Seoul National University Hospital Institutional Review Board
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital Institutional Review Board🇰🇷Seoul, Korea, Republic of