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

Completed · Not applicable · Has a placebo group

Conditions studied: Vaginal Diseases

In brief

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.

Key facts

Study ID

NCT02534779

Run by

CONRAD

People needed

49

Starts

2015-08-01

Expected to finish

2016-03-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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