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Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

NCT03585712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-06-03

Study results available
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Summary

Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill.

To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours.

This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.

Conditions

  • Contraception

Interventions

DRUG

Norgestrel 0.075 mg

Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • HRA Pharma

    lead INDUSTRY

Principal Investigators

  • Alison Edelman, MD · Oregon Health and Sciences University

  • Mitchell Creinin, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2020-04-07
Completion
2020-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585712 on ClinicalTrials.gov