Birth Control

  • STATUS
    Recruiting
  • sponsor
    Evofem
Updated on 25 March 2021

Summary

Birth Control

Description

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.

Details
Condition Birth Control, *Healthy Patient Studies
Clinical Study IdentifierTX152622
SponsorEvofem
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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