Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05294341
Phase
PHASE4
Status
Completed

Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Norethindrone Acetate 5 MG — DRUG
    As specified in arm design
  • Norethindrone 0.35 MG — DRUG
    As specified in arm design

Study Details

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.

Key Dates

Start date
Jul 22, 2022
Status verified
Jul 2024
Primary completion
May 1, 2023
Completion
May 1, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Drug 1
    Half of the subjects will be assigned 0.35mg norethindrone pills daily for 7 days. The other half of the subjects will be 5mg norethindrone acetate pills daily for 7 days.
  • Active Comparator: Drug 2
    Half of the subjects will be assigned 5mg norethindrone acetate pills daily for 7 days. The other half of the subjects will be 0.35mg norethindrone pills daily for 7 days.

Primary Outcome Measure

Serum Concentration of Norethindrone [ Time Frame: Day 1-7 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hershey Medical CenterHersheyPennsylvania17033-

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Hershey Medical Center· Hershey, PA

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