Drug 1 for Birth Control

Hershey Medical Center, Hershey, PA
Norethindrone Acetate 5 MG +1 morePhase 4Waitlist AvailableResearch Sponsored by Milton S. Hershey Medical Center

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your menstrual cycle lasts between 24 and 34 days.


Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ 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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Find a site

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
474 Previous Clinical Trials
2,785,582 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 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. 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
~3 spots leftby Sep 2024