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Therapeutic Areas: Healthy Volunteers
Disease Category: Healthy Patient Studies
Location: United States, CA

Clinical Trial Details

Overview

Research Study Summary

Birth Control

Purpose

Northern California Research is currently enrolling participants for a birth control study. The purpose of this study is to assess the effectiveness of a new form of birth control in preventing pregnancy. The study medication is a new, non-hormonal, birth control designed to maintain the pH of the vagina and to form a layer of gel over the vagina and cervix, preventing sperm from reaching an egg. This medication will be used as needed when engaging in vaginal sexual intercourse.

Our participants will be sexually active women, ages 18-35, who are using no other form of birth control (including condoms). This is not a double-blind study and every participant will be receiving study medication, Amphora. If you are on a birth control method you will be asked to discontinue the use of it in order to participate in this study. The study is 10 months long and includes 5 office visits. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

To Learn more

CW ID: 226713
Date Last Changed: September 18, 2017

Clinical Trial Snapshot

Phase
3
Gender
Female
Age
18 to 35 Years
Overall Status
Recruiting
Lead Sponsor
Evofem
Duration
10 Months
Facility Type
Out-Patient

Eligibility

Inclusion criteria:
  • 18-35 years old
  • Have a regular menstrual cycle, 21-35, days apart each month
  • In a stable relationship with a single partner for at least the last 3 months
  • Be willing to engage in at least three acts of heterosexual vaginal intercourse per month
  • willing to use the study drug as the only method of contraception over the course of the study
Exclusion criteria:
  • Have had three or more UTIs in the past year
  • Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study
  • Be lactating or breastfeeding
  • Have an abnormal Pap test with in the last year

Contact

Iliana Rodriguez, Site Study Specialist
Northern California Research
3840 Watt Avenue, Bldg. E
Sacramento, CA 95821
Phone: 916-484-0500
Fax: 9164840500

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Research Center Information:

Northern California Research

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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