Status:
COMPLETED
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Contraception
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
Brief 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 h...
Detailed Description
Progesterone only pills are utilized as immediate postpartum contraception. Though it is demonstrated to be safe as contraception, it is known to be less efficacious than other forms of progestin-only...
Eligibility Criteria
Inclusion
- Women aged 18-55yo
- Menstrual length cycles 24-34 days
- Previously on non-hormonal forms of contraception
- Ability to follow-up routinely
Exclusion
- 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
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05294341
Start Date
July 22 2022
End Date
May 1 2023
Last Update
July 16 2024
Active Locations (1)
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1
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033