Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®)
Condition: Pregnancy; Sexually Transmitted Disease
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

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®.
    

Detailed 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.
    

Intervention name(s): Wondaleaf®
Intervention type(s): Device
Intervention description(s): Use of Wondaleaf® during sexual intercourse with husband for 5 times in a month period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Condoms, Female; Contraception, Barrier