Pilot Study Examining the Pharmacokinetics of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

19587

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.

2022-07-22

2023-05-01

2023-05-01

Completed

Early phase I

6

Inclusion Criteria: 1. Women aged 18-55yo 2. Menstrual length cycles 24-34 days 3. Previously on non-hormonal forms of contraception 4. Ability to follow-up routinely Exclusion Criteria: 1. Current pregnancy 2. History of anovulatory cycles 3. Irregular cycles (PCOS) 4. On hormonal-based contraception or HRT in past 3 months 5. Infertility or active hormonal treatment of infertility in past 3 months 6. Hx of hysterectomy 7. Postpartum \<3 months 8. H/o liver disease, kidney disease, breast cancer, venous thromboembolism 9. Unwilling to use barrier contraception or abstinence 10. Inability to follow-up routinely

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2023-05-31