A Phase 1, open label, randomized, 2-sequence, 2-period, crossover, single center study to evaluate the pharmacokinetics of follitropin alfa from 2 manufacturing processes, administered as a single subcutaneous 450 IU dose to pituitary-suppressed healthy premenopausal female participants.
Phase 1
Recruiting
- Conditions
- InfertilityMedDRA version: 20.0Level: PTClassification code: 10021928Term: Infertility female Class: 100000004872Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2023-507066-91-00
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method