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

NCT02593214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-03-21

No results posted yet for this study

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®.

Conditions

  • Pregnancy
  • Sexually Transmitted Disease

Interventions

DEVICE

Wondaleaf®

Use of Wondaleaf® during sexual intercourse with husband for 5 times in a month period

Sponsors & Collaborators

  • Twin Catalyst Sdn. Bhd.

    collaborator INDUSTRY

  • Clinical Research Centre, Malaysia

    lead OTHER

Principal Investigators

  • Teck-Hock Toh · Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

  • Loke-Meng Ong · Clinical Research Centre, Penang General Hospital, Penang State Health Department, Ministry of Health Malaysia

  • Shirin Hui Tan · Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

  • Sing Hong Chuo · Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593214 on ClinicalTrials.gov