Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
NCT00702585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2024-08-15
Summary
The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286.
Conditions
Interventions
- DRUG
-
Org 36286
Org 36286 single-dose subcutaneous injection
- DRUG
-
Placebo to Org 36286 as a single-dose subcutaneous injection
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 39 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-08-01
- Primary Completion
- 2002-10-15
- Completion
- 2002-10-15
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