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Trial record 11 of 21 for:    Recruiting, Not yet recruiting, Available Studies | "Sterilization, Reproductive"

Safety and Acceptability Study of a Non-Hormonal Ring

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ClinicalTrials.gov Identifier: NCT03598088
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Daré Bioscience, Inc.

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

Condition or disease Intervention/treatment Phase
Contraception Device: Ovaprene Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Safety and Acceptability Study of a Non-Hormonal Ring
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Healthy Sexually Active Women
Healthy, 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 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.
Device: Ovaprene
non-hormonal contraceptive ring




Primary Outcome Measures :
  1. To evaluate changes from baseline in the Post Coital Test Results (PCT) due to device use. [ Time Frame: 175 Days ]

Secondary Outcome Measures :
  1. To evaluate changes in ferrous gluconate in cervicovaginal fluid between pre-coitus and post-coitus. [ Time Frame: 175 days ]

Other Outcome Measures:
  1. To evaluate changes in cervicovaginal pH pre-coitus and post-coitus in the absence of the study device. [ Time Frame: 175 days ]
  2. To evaluate changes in cervicovaginal pH pre-coitus and post-coitus in the presence of the study device. [ Time Frame: 175 days ]
  3. Incidence of treatment emergent adverse events (safety and tolerability) during use of the device. [ Time Frame: 175 days ]
  4. To evaluate changes from baseline in pelvic exam findings. [ Time Frame: 175 days ]
  5. To evaluate changes from baseline in Nugent score and microflora. [ Time Frame: 175 days ]
  6. To evaluate changes from baseline in antibacterial (anti-E. coli) activity in cervicovaginal fluid. [ Time Frame: 175 days ]
  7. To evaluate changes from baseline in soluble markers of inflammation in cervicovaginal fluid. [ Time Frame: 175 days ]
  8. To evaluate Staphylococcus aureus presence on study devices that have been worn for one cycle. [ Time Frame: 35 days ]
  9. To evaluate group A Streptococcus presence on study devices that have been worn for one cycle. [ Time Frame: 35 days ]
  10. Acceptability of study device among male and female participants using the acceptability questionnaires. [ Time Frame: 175 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females and their male partners to be enrolled.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women aged 18-50 years, inclusive
  2. General good health, by volunteer history and per investigator judgment
  3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
  4. History of Pap tests and follow-up consistent with standard medical practice or willing to undergo a Pap test at Visit 1.
  5. Protected from pregnancy by female tubal sterilization
  6. Willing to abstain from or engage in intercourse with and without condoms and to abstain from other vaginal activity as required in the protocol
  7. In a mutually monogamous relationship for at least the last four months with a male partner who:

    1. Is at least 18 years old;
    2. Has no known risk for STIs;
    3. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and
    4. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
  8. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and genital tract sample collection
  9. Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Exclusion Criteria:

  1. History of hysterectomy
  2. Vasectomy in male partner
  3. Sterility or known history of sperm dysfunction in male partner
  4. Within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome.
  5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera within the last 120 days
  6. Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
  7. Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
  8. Either device does not appropriately fit volunteer, as determined by clinician
  9. Inability of the volunteer to insert, position, and/or remove either device, even with assistance
  10. 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
  11. 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
  12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV
  13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
  14. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
  15. 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)
  16. Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
  17. History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
  18. 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
  19. Nugent score greater than or equal to 7
  20. Systemic use in the last two weeks or anticipated use during the study of antibiotics (other than those used to treat UTI, vaginal candidiasis, or 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.
  21. 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)
  22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
  23. Inadequate sperm in endocervical aspirate during baseline testing without any device, despite adequate mucus and presence of sperm in vaginal pool

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598088


Contacts
Contact: Nadene A. Zack, MS 619-723-3192 nzack@darebioscience.com

Locations
United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: Annie Thurman, MD    757-446-7971    ThurmaAR@EVMS.EDU   
Principal Investigator: Annie Thurman, MD         
Principal Investigator: Jeffrey Jensen, MD         
Principal Investigator: Courtney Schreiber, MD         
Principal Investigator: Melody Hou, MD         
Sponsors and Collaborators
Daré Bioscience, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Nadene A. Zack, MS Sr Director, Clinical Operations

Responsible Party: Daré Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT03598088     History of Changes
Other Study ID Numbers: DR-OVP-001
1R44HD095724-01 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No