Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®)

Pregnancy Clinical Trial

Official title: A Clinical Trial to Asses the Performance and Safety of an Innovative Female Condom (Wondaleaf®) Among Healthy Married Couples

Status Completed

Clinical Trial Summary

General objective:

To assess the performance and safety profile of a novel innovative design of female condom (Wondaleaf®) among healthy married women.

Specific objectives :

• To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical breakage, invagination, misdirection, and slippage.

• To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and their spouses.

• To assess the safety profile of Wondaleaf®.

Clinical Trial Description

This is a single-centre clinical trial to assess the performance and safety profile of Wondaleaf® in healthy married women. Referrals from doctors and nurses in the Maternal and Child Health Clinics, Family Planning Clinics and private clinics in Sibu will be received. A total of 63 couples will be recruited to use Wondaleaf® and to study self-reported total clinical failure and total female condom failure and their components failure events of clinical breakage, non-clinical breakage, total breakage, slippage, misdirection, and invagination (as per World Health Organisation (WHO) Female Condom Technical Review Committee definition(1)). Secondary outcomes were safety parameters (retention of investigational device intra-vaginally should it break, complaint of sexually transmitted diseases, vaginal infection and/or urinary tract infections, all adverse events, serious adverse events, adverse device events and serious adverse device events, allergic reaction) as well as acceptability and satisfaction of the use of Wondaleaf®.

A focus group discussion will be held for the first two couples, to a maximum of five couples recruited based on the same inclusion and exclusion criteria will be asked to trial the process of training / counselling of using the condom, as well as completing the coital log. Experience gathered from these focus group testing and discussion, will be used to enhance the strength of this protocol.

Subsequently, each couple will be asked to use five Wondaleaf® and to complete a coital log at home after each condom use. Before putting on the investigational device, the subject must check for device or package breakage. During sexual intercourse, the couple ought to notice if any breakage of the condom has occurred, and if the female condom slips completely out of the vagina or the penis of male spouse is inserted between the condom and the vaginal wall as well as event of invagination (when the external retention feature of the female condom is partly or fully pushed into the vagina).

Each subject must maintain the wearing of investigational device for the entire process of intercourse until the male spouse ejaculate intra-vaginally. Following each ejaculation of the male spouse, the investigational devices must be checked for breakage before, during and after withdrawal of the condom from the vagina. A coital log must be completed by the couples within 12 hours after the use of each investigational device. Coital logs are used to obtain data for condom performance and safety. The five female investigational devices should be used within a period of four weeks. The used investigational devices shall be discarded safely in the usual and safe manner at home.

After the women completed five uses of Wondaleaf® or after four weeks (whichever occurs first), they will return to the clinic to return their coital log and to fill out an acceptability and satisfaction questionnaire. Any unused female investigational devices (i.e. the female condom) will be returned for counting purposes.

If the women were confirmed pregnant during study period, the subjects will be withdrawn from the study. The married couple will be referred for antenatal care of their choice. ;

Related Conditions & MeSH terms

• Pregnancy
• Sexually Transmitted Disease
• Sexually Transmitted Diseases

• NCT number: NCT02593214
• Study type: Interventional
• Source: Clinical Research Centre, Malaysia
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: September 2016