Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel

NCT02309554 | Completed Phase 1

• 1 other identifier: A13-126
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 2

Brief Summary

This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.

Conditions

Contraception

Keywords

Contraception; Post coital test; Vaginal; Diaphragm

Outcome Measures

Primary Outcomes (2)

• Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness

  Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle.

  2-3 hours following coitus

• Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness.

  Mean, median, standard deviation and IQR will be assessed for the baseline cycle and during each test PCT, across all women. Qualitative assessments of change from baseline, if any, will be based on medians and IQRs.

  2-3 hours following coitus

Secondary Outcomes (2)

• Number of treatment emergent adverse experiences among female participants as a measure of safety

  Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months

• Number of treatment emergent adverse experiences among male partners as a measure of safety

  Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months

Study Arms (3)

SILCS Diaphragm alone

ACTIVE COMPARATOR

Participants will complete a post-coital test cycle with SILCS diaphragm alone.

Other: SILCS diaphragm

SILCS Diaphragm with 3% Nonoxynol-9 Gel

ACTIVE COMPARATOR

Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel.

Other: SILCS diaphragm used with 3% Nonoxynol-9; Other: SILCS diaphragm

SILCS Diarphragm with ContraGel

EXPERIMENTAL

Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel.

Other: SILCS diaphragm used with ContraGel; Other: SILCS diaphragm

Interventions

SILCS diaphragm used with ContraGel OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.

SILCS Diarphragm with ContraGel

SILCS diaphragm used with 3% Nonoxynol-9 OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.

SILCS Diaphragm with 3% Nonoxynol-9 Gel

SILCS diaphragm OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

SILCS Diaphragm alone; SILCS Diaphragm with 3% Nonoxynol-9 Gel; SILCS Diarphragm with ContraGel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 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 smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1
• Willing to abstain from intercourse and use of vaginal products as required in the protocol
• Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle
• In a mutually monogamous relationship for at least the last four months with a male partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
• Protected from pregnancy by female tubal sterilization
• Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
• Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

You may not qualify if:

• History of hysterectomy
• Vasectomy in male partner
• Sterility or known history of sperm dysfunction in male partner
• Currently pregnant or 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, or use of Depo-Provera in 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
• Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
• Device does not appropriately fit volunteer, as determined by clinician
• Inability to insert, position, and/or remove study device, by clinician or volunteer
• History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner
• In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women 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 or Chlamydia trachomatis
• Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
• Positive test for HIV
• Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)

Sponsors & Collaborators

• CONRAD: lead

Study Sites (2)

Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

ProFamilia

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

Nonoxynol

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: December 5, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07

Locations

US (1); DO (1)