Safety and Acceptability Study of a Non-Hormonal Ring

Contraception Clinical Trial

Official title:

Safety and Acceptability Study of a Non-Hormonal Ring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598088
• Other study ID #: DR-OVP-001
• Secondary ID: 1R44HD095724-01
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: June 2022
• Source: Daré Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 15, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Sexually Transmitted Infections (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 (intra-uterine device), 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 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.

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Ovaprene
non-hormonal contraceptive ring

Locations

Country	Name	City	State
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Segal Trials	North Miami	Florida
United States	University of Pennsylvania Penn Obstetric Gynecology Associates	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California at Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Daré Bioscience, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device.	Evaluating the change in CVF pH before and after sex with no device present.	Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs)
Other	Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device.	Evaluating the change in CVF pH before and after intercourse when the Ovaprene device was being worn during intercourse.	OVP Cycle A Visit 13 (Day 121) to Visit 14 (Day 122) and OVP Cycle B Visit 18 (Day 156) to Visit 19 (Day 157).
Other	Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device.	Number of participants within the Ovaprene population that experienced a Urogenital treatment emergent adverse event (AE).	175 days
Other	Number of Participants With Changes in Pelvic Exam Findings From Baseline	Pelvic exams were completed at all 21 visits via a vaginal Colposcopy procedure.	175 days
Other	Changes From Baseline in Nugent Score	Nugent scores were calculated prior to the insertion of each Ovaprene device and then after the device was removed at the end of each cycle.; Nugent score is a gram stain storage system assessing vaginal bacteria present on a scale of 0-10. Scores ranging from 7-10 are indicative of bacterial vaginosis.	175 days
Other	Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid.	Measuring the E.coli inhibition (%) pre and post intercourse	Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157).
Other	Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid.	Measurement of Interleukin-1 Beta (pg IL-1Beta/ug Protein), Interleukin-8 (pg IL-8/ug Protein), Secretory leukocyte Peptidase Inhibitor (SLPI)	Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157).
Other	Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device.	Vaginal samples and swabs of the used Ovaprene devices were tested for growth of staphylococcus aureus.	35 days (one complete cycle)
Other	Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle.	Vaginal samples and swabs of the used Ovaprene devices were tested for group A Streptococcus.	35 days (one full cyle)
Other	Summary of the Acceptability of the Study Device Among Male and Female Participants.	Summary of Open-Ended Acceptability Questionnaire	175 days
Other	Participants Who Could be Fitted With the Ovaprene Device		Screening or BP3 Visit (2 days)
Other	Participants That Could Correctly Insert, Position and Remove the Ovaprene Device	Number of participants that required written instructions, those who required written and verbal instructions and those who needed physical assistance.	Visit 3 (BP3, Day 15-20); Visit 7 (OS1, Day 84); Visit 12 (OP1a, Day 112); Visit 13 (OP2a, Day 122-132); Visit 17 (OP1b, Day 140); UNS could occur at any point during the 175 day study duration
Other	Location of Ovaprene in Relation to Cervix	Location was determined digitally and visually by the investigators.	175 days
Primary	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.	Baseline to OVP PCTa at 175 Days