CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 6 enrolled
Drug / intervention
Norethindrone Acetate 5 MG +1 moredrug
Likely dose
Norethindrone Acetate 5 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05294341
NCT05294341Phase 4Completed
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Pilot Study Examining the Pharmacokinetics of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

Milton S. Hershey Medical Center·interventional·Posted Mar 24, 2022·Updated Jul 16, 2024

In Brief

A Phase 4 clinical trial evaluating Norethindrone Acetate 5 MG and Norethindrone 0.35 MG for Contraception. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 24, 2022
Enrollment StartJul 22, 2022
Primary CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.3 years ago

Interventions

Norethindrone Acetate 5 MGdrug

As specified in arm design

Norethindrone 0.35 MGdrug

As specified in arm design