AzTrials
AzTrials

ContraceptionNCT03598088

Safety and Acceptability Study of a Non-Hormonal Ring

A study testing Ovaprene in people with Contraception, run by Daré Bioscience, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a feasibility, multi-center, open-label, non-significant risk device study for a non-hormonal contraceptive ring. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Ovaprene
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
6 sitesUnited States
Study dates
23 May 2018to 15 Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women aged 18-50 years, inclusive
  • General good health, by volunteer history and per investigator judgment
  • History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
  • History of Pap tests and follow-up consistent with standard medical practice or willing to undergo a Pap test at Visit 1.
  • Protected from pregnancy by female tubal sterilization
  • Willing to abstain from or engage in intercourse with and without condoms and to abstain from other vaginal activity as required in the protocol
Show all 13Show fewer
  • In a mutually monogamous relationship for at least the last four months with a male partner who:
  • Is at least 18 years old;
  • Has no known risk for Sexually Transmitted Infections (STIs);
  • Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and
  • Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
  • Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and genital tract sample collection
  • Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Who cannot join

  • History of hysterectomy
  • Vasectomy in male partner
  • Sterility or known history of sperm dysfunction in male partner
  • Within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome.
  • Current use of any hormonal contraceptive or a copper IUD (intra-uterine device), or use of Depo-Provera within the last 120 days
  • Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
Show all 23Show fewer
  • Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
  • Either device does not appropriately fit volunteer, as determined by clinician
  • Inability of the volunteer to insert, position, and/or remove either device, even with assistance
  • History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of Ovaprene™ or Caya, for either the volunteer or her male partner
  • In the last four months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women or male partners with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
  • Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV
  • Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
  • Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
  • Known current drug or alcohol abuse which could impact study compliance. (This is defined as any illicit drug use or more than 15 alcoholic drinks per week)
  • Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
  • History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
  • Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
  • Nugent score greater than or equal to 7
  • Systemic use in the last two weeks or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), vaginal candidiasis, or bacterial vaginosis (BV) diagnosed at Visit 1, or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g., acyclovir or valacyclovir). Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in treatment of headaches or dysmenorrhea.
  • Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for Grading of the Severity of Adverse Events or clinically significant lab abnormalities as determined by the investigator (see Section 13.5 for link to DAIDS table)
  • Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
  • Inadequate sperm in endocervical aspirate during baseline testing without any device, despite adequate mucus and presence of sperm in vaginal pool

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Segal Trials

    North Miami, Florida, 33161

  • University of Pennsylvania Penn Obstetric Gynecology Associates

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of California at Davis

    Sacramento, California, 95817

Other trials in United States

About this study

This is a feasibility, multi-center, open-label, non-significant risk device study for a non-hormonal contraceptive ring.

Read the detailed description

The purpose of this clinical trial is to assess the ability of Ovaprene™ to prevent sperm from penetrating midcycle cervical mucus. In addition, safety, release of ingredients, acceptability and fit will be assessed.

Conditions
Contraception
Being tested
Ovaprene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OvapreneDevice

    non-hormonal contraceptive ring

Study groups in NCT03598088
Study groupRoleWhat they receive
Healthy Sexually Active WomenOtherHealthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene and the Caya diaphragm throughout the course of the trial. The purpose of the Caya Post Coital Test (PCT) cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated.
Receives: Device: Ovaprene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use.

    All participants had fewer than 5 progressively motile sperm per high power field (PMS/HPF) in all cycles during Ovaprene use.

    Measured: Baseline to OVP PCTa at 175 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start23 May 2018
  3. Primary completion17 Oct 2019
  4. Study completion15 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03598088
Sponsor's protocol ID
DR-OVP-001
Other IDs
1R44HD095724-01
Status last verified
Jun 2022
First submitted
21 Jun 2018
Last updated
8 Jun 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Mauck C, Thurman A, Jensen JT, Schreiber CA, Baker J, Hou MY, Chavoustie S, Dart C, Wu H, Ravel J, Gajer P, Herold BC, Jacot T, Zack N, Hatheway J, Friend D. Safety testing of Ovaprene: An investigational nonhormonal monthly vaginal contraceptive. Contraception. 2024 Jul;135:110440. doi: 10.1016/j.contraception.2024.110440. Epub 2024 Mar 27.

    PubMed 38552818

Questions about this trial

What is this clinical trial studying?

A study testing Ovaprene in people with Contraception, run by Daré Bioscience, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. (time frame: Baseline to OVP PCTa at 175 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598088, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in