Trials / Completed
CompletedNCT00647933
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 18 Years – 38 Years
- Healthy volunteers
- Accepted
Summary
The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Org 36286 | Subcutaneous Org 36286 |
| DRUG | Lyndiol® | Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks. |
Timeline
- Start date
- 2000-06-01
- Primary completion
- 2000-12-01
- Completion
- 2000-12-01
- First posted
- 2008-04-01
- Last updated
- 2022-02-03
Source: ClinicalTrials.gov record NCT00647933. Inclusion in this directory is not an endorsement.