Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

Completed · Phase 4

Conditions studied: Contraception

In brief

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 facts

Study ID

NCT05294341

Run by

Milton S. Hershey Medical Center

People needed

6

Starts

2022-07-22

Expected to finish

2023-05-01

Last updated by the study team

2024-07-16

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women aged 18-55yo
• Menstrual length cycles 24-34 days
• Previously on non-hormonal forms of contraception
• Ability to follow-up routinely

You may not qualify if…

• Current pregnancy
• History of anovulatory cycles
• Irregular cycles (PCOS)
• On hormonal-based contraception or HRT in past 3 months
• Infertility or active hormonal treatment of infertility in past 3 months
• Hx of hysterectomy
• Postpartum <3 months
• H/o liver disease, kidney disease, breast cancer, venous thromboembolism
• Unwilling to use barrier contraception or abstinence
• Inability to follow-up routinely

Where it is running

• Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.