Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products

NCT02534779 | Completed

• 1 other identifier: D15-134
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.

Conditions

Vaginal Diseases

Outcome Measures

Primary Outcomes (3)

• Time to disintegration (insert no longer coherent but residual product is visible)

  Up to 90 minutes post-insertion

• Percent of inserts that partially/fully disintegrate and completely disappear at each time point of observation

  Up to 90 minutes post use

• Time to complete disappearance

  Up to 90 minutes post-insertion

Secondary Outcomes (2)

• Abnormal findings related to study product on pelvic examination by naked eye exam

  Up to 90 minutes post use; 24-72 hours post at-home use

• Genitourinary adverse events after use of inserts

  Up to 90 minutes post use; 24-72 hours post at-home use

Other Outcomes (1)

• Responses on acceptability questionnaire after a single use of a vaginal insert

  4 hours and 24 hours post at-home use

Study Arms (1)

Placebo Vaginal Insert

EXPERIMENTAL

Placebo insert

Other: Placebo Vaginal Insert

Interventions

Placebo Vaginal Insert OTHER

Placebo insert

Placebo Vaginal Insert

Eligibility Criteria

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

You may qualify if:

• Age 18-50 years, inclusive
• General good health (by volunteer history and investigator judgment)
• Currently having regular menstrual cycles of 21 - 35 days by volunteer report
• Protected from pregnancy, meaning one of the following: Sexually abstinent and planning to remain abstinent for the duration of the study; In a monogamous heterosexual relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for sexually transmitted infections (STIs) and: Couple is using condoms and is willing to use non-spermicidally lubricated condoms throughout the study or One partner is sterilized; or in a monogamous same-sex relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for STIs.
• Willing to abstain from vaginal activity and vaginal product use as required in the protocol
• Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy examination
• 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
• 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
• Use of any hormonal contraceptive method in the last 30 days (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device)
• Injection of Depo-Provera in the last 6 months
• Current use of copper intrauterine device (IUD)
• Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
• History of sensitivity/allergy to any component of the study products
• Symptomatic reproductive tract infection (RTI)
• Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
• Known current drug or alcohol abuse which could impact study compliance
• Participation in any other investigational trial (device, drug, or vaginal trial) within the last 30 days or planned participation in any other investigational trial during the study
• History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
• Abnormal finding on physical examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

Sponsors & Collaborators

• CONRAD: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jill Schwartz, MD

  CONRAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 28, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-06

Locations

US (1)