Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6

NCT01452503 | Completed

• 2 other identifiers: 9928USAID
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of preference for three female condoms (FC).

Conditions

Contraception

Keywords

AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonization; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot

Outcome Measures

Primary Outcomes (1)

• Preference of female condom by type

  The objective of Part 1 is to familiarize each participant with the use characteristics of the three female condom types in order to minimize learning curve effect in subsequent phases of study. In Part 2, a 'simulated market' will be created in order to determine an unbiased, free choice preference for a particular FC type. Part 3 will detail the reasons for participants' selection/preference of specific FC types.

  3 months

Secondary Outcomes (2)

• Safety of each of the female condom types

  3 months

• Function of each of the female condom types

  3 Months

Study Arms (3)

PATH Women's Condom

ACTIVE COMPARATOR

PATH Women's Condom

Device: Path Women's Condom

FC2 female condom

ACTIVE COMPARATOR

Female Health Company's FC2 female condom

Device: FC2 female condom

Reddy 6 female condom (V-Amour)

ACTIVE COMPARATOR

Reddy 6 female condom (Commercially known as the V-Amour female condom)

Device: Reddy 6 female condom (V-Amour)

Interventions

Path Women's Condom DEVICE

comparison between 3 types of female condoms

PATH Women's Condom

FC2 female condom DEVICE

comparison between 3 types of female condoms

FC2 female condom

Reddy 6 female condom (V-Amour) DEVICE

comparison between 3 types of female condoms

Reddy 6 female condom (V-Amour)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women enrolled in this research must meet the following selection criteria:
• must be at least 18 years of age.
• must be literate (able to read a newspaper or letter easily).
• must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
• must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
• must have been in a sexual relationship with this partner for at least 6 months.
• must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
• must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
• must be willing to give informed consent.
• must be able to complete condom use log.
• must be willing to use the study condoms as directed.
• must be willing to adhere to the follow-up schedule and all study procedures.
• must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
• must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
• must be willing to participate in the study for up to six months.

You may not qualify if:

• must not be a sex worker.
• must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
• must not be breastfeeding.
• must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.

Sponsors & Collaborators

• FHI 360: lead
• United States Agency for International Development (USAID): collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Commercial City Clinic Department of Health

Durban, 4001, South Africa

Location

Related Publications (1)

• Beksinska M, Smit J, Joanis C, Hart C. Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception. 2012 Aug;86(2):127-31. doi: 10.1016/j.contraception.2011.11.071. Epub 2012 Jan 20.

  PMID: 22264667 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mags Beksinska, MSc. PhD

  RHRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: October 17, 2011
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)