A Safety Study Of The Caya® Diaphragm Used With ContraGel®

NCT02462954 | Completed Phase 1

• 1 other identifier: A13-127
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of ContraGel versus the hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use, the first without intercourse and the second with intercourse.

Conditions

Contraception

Keywords

Contraception; Vaginal Gel; Diaphragm

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse experiences (TEAEs) among female participants: urogenital, product-related, and/or serious

  after two 7-day periods of daily use, the first without intercourse and the second with intercourse

• Changes from baseline in the following safety endpoints [composite]:

  * Findings on pelvic exam, including colposcopy * Vaginal pH (measure of acidity and alkalinity), Nugent score, and microflora * Anti-bacterial activity in cervicovaginal fluid (CVF) * Soluble markers of inflammation in cervicovaginal fluid (CVF) * Epithelial integrity and immune cell activation/phenotype in genital tissues * Findings on pelvic exam, including colposcopy * Vaginal pH, Nugent score, and microflora * Anti-bacterial activity in cervicovaginal fluid (CVF) * Soluble markers of inflammation in cervicovaginal fluid (CVF) * Epithelial integrity and immune cell activation/phenotype in genital tissues

  after two 7-day periods of daily use, the first without intercourse and the second with intercourse

Study Arms (2)

ContraGel

EXPERIMENTAL

ContraGel, a personal lubricant has a Conformite Europeenne (CE) mark and has been used with barrier devices in Europe and other countries outside the US, but it is not currently approved by the US FDA.

Device: ContraGel

HEC Placebo

PLACEBO COMPARATOR

The placebo gel is supplied by CONRAD in pre-filled individual applicators, each applicator containing 4.0 mL of HEC gel. Placebo gel contains HEC as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide.

Device: HEC Universal Placebo gel

Interventions

ContraGel DEVICE

ContraGel

HEC Universal Placebo gel DEVICE

HEC Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers must meet all of the following criteria prior to genital sampling at Visit 2.
• Age 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 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 and engage in intercourse and abstain from the use of vaginal products as required in the protocol
• In a mutually monogamous relationship for at least the last four months with a male partner who:
• Is at least 18 years old
• Is willing and able to comply with protocol requirements including sexual activity/abstinence requirements
• Can engage in vaginal intercourse with the participant without condoms, as specified in protocol
• Has no known risk for sexually transmitted infections (STIs)
• Has no known history of sensitivity/allergy to any component of ContraGel, HEC placebo gel, silicone or nylon
• Protected from pregnancy by female sterilization
• 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

You may not qualify if:

• Volunteers must meet none of the following criteria prior to genital sampling at Visit 2.
• History of hysterectomy
• 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 (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device) or a copper intrauterine device (IUD), or use of Depo-Provera in the last 6 months
• 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)
• Caya diaphragm does not appropriately fit volunteer, as determined by clinician
• Inability to insert, position, and/or remove Caya diaphragm by volunteer
• History of sensitivity/allergy to any component of ContraGel, HEC placebo gel, K-Y® Jelly, topical anesthetic, silicone or nylon, and to both silver nitrate and Monsel's solution
• In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease by self report. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
• Nugent score greater than or equal to 7
• 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
• Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy
• Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)

Sponsors & Collaborators

• CONRAD: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Thurman A, Cunningham T, Fichorova R, Herold BC, Hillier SL, Chandra N, Doncel GF. A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel. Contraception. 2019 Dec;100(6):430-437. doi: 10.1016/j.contraception.2019.06.004. Epub 2019 Aug 21.

  PMID: 31442441 DERIVED

Study Officials

• Christine Mauck

  CONRAD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 4, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)