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NCT05294341 · ClinicalTrials.gov registry record · Phase 4
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
A Phase 4 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT05294341: Completed Phase 4 study, sponsored by Milton S. Hershey Medical Center.
NCT05294341 is a Phase 4 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05294341, a Phase 4 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
0.35mg norethindrone, also known as progesterone only pills, are routinely prescribed as immediate postpartum oral contraception. Norethindrone acetate is prescribed for gynecologic indications, but has never been studied as an efficacious form of contraception. This is a pilot crossover study examining the pharmacokinetics of norethindrone, the metabolically active component of both drugs, in participants taking 5mg norethindrone and 0.35mg norethindrone acetate.
Primary Outcome
The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed daily over one week of medication use. Norethindrone levels are then averaged across all subjects teaching each medication in each sequence for days 1-7.
Interventions
- DRUG Norethindrone Acetate 5 MG
- DRUG Norethindrone 0.35 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 4 |
What the finished NCT05294341 record still lists
NCT05294341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Norethindrone Acetate 5 MG is the first listed.
NCT05294341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05294341 about?
NCT05294341 is a clinical study titled "Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate". 0.35mg norethindrone, also known as progesterone only pills, are routinely prescribed as immediate postpartum oral contraception. Norethindrone acetate is prescribed for gynecologic indications, but has never been studied as an efficacious form of contraception. This is a pilot crossover study exami...
What is the current status of trial NCT05294341?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2022-07-22. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT05294341?
The interventions under investigation include: Norethindrone Acetate 5 MG (DRUG), Norethindrone 0.35 MG (DRUG).
Who is sponsoring clinical trial NCT05294341?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05294341's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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