drugset / Trial / NCT05294341

Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

NCT05294341

Phase 4 Completed 6 enrolled Milton S. Hershey Medical Center
Non-randomizedCrossoverOpen-labelOther

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.

Timeline

Start
2022-07-22
Primary completion
2023-05-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Norethindrone Unknown 0.35 mg Oral
Comparator Norethindrone Unknown 5 mg Oral

Indications

No indication recorded.