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NCT03662516 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects
A Phase 1 study of Healthy Females, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03662516: Completed Phase 1 study of Healthy Females, sponsored by Pfizer.
NCT03662516 is a Phase 1 study of Healthy Females that has completed, run by Pfizer. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03662516, a Phase 1 study of Healthy Females, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 04965842 on single-dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 16 healthy female subjects (8 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.
Primary Outcome
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Conditions Studied
Interventions
- DRUG PF-04965842
- DRUG Ethinyl estradiol (EE) and levonorgestrel (LN)
Study Locations (1)
Connecticut
- Pfizer New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2019-01-19 |
| Phase | Phase 1 |
What the finished NCT03662516 record still lists
NCT03662516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Healthy Females appearing as the primary indexed condition, and to 2 interventions - of which PF-04965842 is the first listed.
NCT03662516 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03662516 about?
NCT03662516 is a clinical study titled "A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects". This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 04965842 on single-dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 16 healthy female subjects (8 in each treatment sequence) will be enrolle...
What is the current status of trial NCT03662516?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-09-26. Estimated completion is 2019-01-19.
What conditions does trial NCT03662516 study?
This clinical trial studies the following conditions: Healthy Females.
What interventions are being tested in trial NCT03662516?
The interventions under investigation include: PF-04965842 (DRUG), Ethinyl estradiol (EE) and levonorgestrel (LN) (DRUG).
Who is sponsoring clinical trial NCT03662516?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03662516 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03662516's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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