Clinical trial NCT03598088: Safety and Acceptability Study of a Non-Hormonal Ring
Official title: Safety and Acceptability Study of a Non-Hormonal Ring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Daré Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-07-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

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.

Eligibility 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 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

Primary outcomes:
measure: Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use.
timeFrame: Baseline to OVP PCTa at 175 Days
Secondary outcomes:
Other outcomes:
measure: Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device.
timeFrame: Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs)
measure: Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device.
timeFrame: 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).
measure: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device.
timeFrame: 175 days
measure: Number of Participants With Changes in Pelvic Exam Findings From Baseline
timeFrame: 175 days
measure: Changes From Baseline in Nugent Score
timeFrame: 175 days
measure: Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid.
timeFrame: 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).
measure: Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid.
timeFrame: 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).
measure: Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device.
timeFrame: 35 days (one complete cycle)
measure: Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle.
timeFrame: 35 days (one full cyle)
measure: Summary of the Acceptability of the Study Device Among Male and Female Participants.
timeFrame: 175 days
measure: Participants Who Could be Fitted With the Ovaprene Device
timeFrame: Screening or BP3 Visit (2 days)
measure: Participants That Could Correctly Insert, Position and Remove the Ovaprene Device
timeFrame: 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
measure: Location of Ovaprene in Relation to Cervix
timeFrame: 175 days
Locations:
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: North Miami
country: United States
facility: Segal Trials
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Penn Obstetric Gynecology Associates
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Sr Director, Clinical Operations
name: Nadene A. Zack, MS
role: STUDY_DIRECTOR
References: