Phase 4
N=6
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT05294341 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Serum Concentration of Norethindrone — 15.69; 2.28; 13.56; 2.50 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Norethindrone Acetate 5 MG (Drug); Norethindrone 0.35 MG (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Concentration of Norethindrone |
15.69; 2.28; 13.56; 2.50; 13.96; 2.28 | — |
| SECONDARY Day 8 Norethindrone Levels |
1.54; 0.14729; 1.17; 0.129893333; 1.31; 0.149843333 | — |
| SECONDARY Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone |
34.7; 33.5; 147; 139; 0.45; 0.44 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women aged 18-55yo
- Menstrual length cycles 24-34 days
- Previously on non-hormonal forms of contraception
- Ability to follow-up routinely
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05294341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.