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Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

NCT05294341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-07-16

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

Norethindrone Acetate 5 MG

As specified in arm design

DRUG

Norethindrone 0.35 MG

As specified in arm design

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2023-05-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05294341 on ClinicalTrials.gov