Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

NCT05294341 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19587
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Contraception

Keywords

pharmacokinetics; pilot study

Outcome Measures

Primary Outcomes (1)

• Serum Concentration of Norethindrone

  The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed daily over one week of medication use. Norethindrone levels are then averaged across all subjects teaching each medication in each sequence for days 1-7.

  Day 1-7

Secondary Outcomes (2)

• Day 8 Norethindrone Levels

  Hourly for eight hours on Day 8

• Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone

  Day 1 and Day 21

Study Arms (2)

Drug 1

ACTIVE COMPARATOR

Half of the subjects will be assigned 0.35mg norethindrone pills daily for 7 days. The other half of the subjects will be 5mg norethindrone acetate pills daily for 7 days.

Drug: Norethindrone Acetate 5 MG; Drug: Norethindrone 0.35 MG

Drug 2

ACTIVE COMPARATOR

Half of the subjects will be assigned 5mg norethindrone acetate pills daily for 7 days. The other half of the subjects will be 0.35mg norethindrone pills daily for 7 days.

Drug: Norethindrone Acetate 5 MG; Drug: Norethindrone 0.35 MG

Interventions

Norethindrone Acetate 5 MG DRUG

As specified in arm design

Drug 1; Drug 2

Norethindrone 0.35 MG DRUG

As specified in arm design

Drug 1; Drug 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Norethindrone Acetate; Norethindrone

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Halina Yee; Primary Resident Investigator
• Organization: Hershey Medical Center

hyee@pennstatehealth.psu.edu

7175313503

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 24, 2022
• Study Start: July 22, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Locations

US (1)