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Progestin

Drug 1 for Birth Control

Phase 4

Waitlist Available

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 21

Awards & highlights

Study Summary

This trial is examining how different doses of progesterone-only pills affect the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum concentration of norethindrone

Secondary outcome measures

Differences of serum levels of estradiol, luteinizing hormone (LH), follicle stimulating hormone (FSH), and progesterone

The elimination rate of norethindrone

Trial Design

2Treatment groups

Active Control

Group I: Drug 1Active Control2 Interventions

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.

Group II: Drug 2Active Control2 Interventions

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,816 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for this medical experiment?

"Affirmative. Data posted on clinicaltrials.gov affirm that this medical experiment, initially posted on July 22nd 2022, is presently recruiting participants. 6 individuals need to be sourced from one facility for the trial's completion."

Answered by AI

Does the research allow for geriatric patients to participate?

"The upper-age limit for this trial has been set at 55 years, whilst the lower age is 18."

Answered by AI

What is the total number of participants in this research endeavor?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is actively searching for participants, with the initial post being made on July 22nd 2022 and most recently modified on August 4th 2022. 6 people need to be recruited from one medical centre."

Answered by AI

What potential hazards should patients be aware of when taking Drug 1?

"Based on previous clinical trials and the current Phase 4 status of Drug 1, our team at Power estimates it's safety to be a 3."

Answered by AI

Am I eligible to be a test subject in this clinical experiment?

"This medical research is recruiting 6 patients from 18 to 55 years old, all of whom are actively using contraception. To be eligible for the study, participants must have menstrual cycles between 24-34 days in length, use non-hormonal forms of birth control and demonstrate their ability to come back regularly for follow up appointments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

Sarah Horvath, MD, MSHP 2022. "Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05294341.