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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02593214
• Date of registration: 27/10/2015
• Prospective Registration: No
• Primary sponsor: Clinical Research Centre, Malaysia
• Public title: Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®)
• Scientific title: A Clinical Trial to Asses the Performance and Safety of an Innovative Female Condom (Wondaleaf®) Among Healthy Married Couples
• Date of first enrolment: August 2015
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02593214
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malaysia

Contacts

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

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

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

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Sexually active and legally married couples both between 21 and 45 years of age, and
who have been in sexual relationship for at least 6 months;

- Married couples who are willing to participate (i.e. maintain sexually active and
agree to have penile-vaginal intercourse with frequency sufficient to meet protocol
requirements) and having signed informed consent form;

- Married women willing to have physical examination of the genitalia by the
investigator (who is a medical doctor);

- Married women who are willing to take urine pregnancy test;

- Married couples who are planning to get pregnant, but do not mind delaying it;

- Married couples who are not planning for pregnancy soon, yet do not mind getting
pregnant (however if found pregnant during the study period, study for the couple will
be terminated);

- Married woman and/or her spouse who are on effective contraception (e.g. oral
contraceptive, intrauterine device, injectable, patch), or female / male sterilisation
methods before entering the study and able to maintain the contraception throughout
the study period;

- Married couples who agree to use only study female condom during the time of
participation;

- Married couples who are able to understand instructions for correct use of study
female condoms;

- Married couples who agree not to use male condom when using the study female condom in
a single sexual intercourse;

- Married couples who agree not to use drugs or non-study devices that affect sexual
performance;

- Married couples who agree not to wear any genital piercing jewellery while using study
female condoms;

- Literate married couple who can complete the study questionnaire and coital log on
their own in language of their choice (English, Chinese, or Malay);

- Married couples who are able to comply with completing questionnaire and coital log,
as well as attending all study visits.

Exclusion Criteria:

- Female subject with known history of untreated or suspected sexually transmitted
infection(s) including HIV/AIDS, vaginal or uterine infection(s), and/or urinary tract
infections;

- Female subject with a history of abnormal Pap smear or cervical / uterine diseases;

- Female subject who is pregnant (established by urine pregnancy test), or desires to
become so while participating in study;

- Either one of the married couple who have known history of allergy to the devices or
materials used to manufacture the investigational devices, or any female or male
condom, or lubricants that are used on the devices;

- Those staff who work directly under the investigators and/or employed directly by the
device manufacturers, sponsor and study team;

- Female subject who have menopausal symptom (12 months history with no bleeding unless
because of contraceptive methods);

- Male subject who has known erectile or ejaculatory dysfunction;

- Either one of the married couple who had history of hospitalisation because of acute
illness within three months before Visit 1;

- Either one of the married couple is using any medications or preparation applied
topically or intravaginal to the genitalia, other than that supplied for the study
(subjects can be rescreened 14 days after the recovery, if the application are for
acute illness);

- Any married couple who have received advice from their medical doctor for not engaging
in sexual intercourse during the intended study period because of their health
conditions, which may include chronic disease or chronic administration (defined as
more than 14 days in total) of any medicine, based on medical history and physical
examination (no laboratory testing required);

- Women subject and/or their spouse taking medicine which is known to influence sexual
performance / libido, or to cause impotence, for any reasons, 30 days before visit 1,
and during the intended study period (no laboratory testing required);

- Acute disease at the time of enrolment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. Fever is defined as axillary /
tympanic / rectal temperature = 38°C. Subjects can be rescreened 14 days after the
recovery;

- Active untreated tuberculosis or communicable diseases of the women subjects and/or
their spouse based on medical history;

- Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other
malignant neoplasms affecting the bone marrow or lymphatic systems;

. The couple concurrently participating in another clinical study involving female
and/or male condom;

- Presence of a clinically significant disorder involving the cardiovascular,
respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine,
or nervous system(s) or psychiatric disease or other conditions that may interfere
with the health conditions (such as in case the women subject become pregnant), or
would place the subjects at increased risk, as determined by the investigator(s).



Age minimum: 21 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sexually Transmitted Disease

Pregnancy

Intervention(s)

Device: Wondaleaf®

Primary Outcome(s)

Total female condom failure [Time Frame: Five uses of investigational devices, an average of one month]

Secondary Outcome(s)

Non-clinical breakage [Time Frame: Five uses of investigational devices, an average of one month]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: Five uses of investigational device, an average of one month]

Satisfaction [Time Frame: Five uses of investigational device, an average of one month]

Total clinical failure [Time Frame: Five uses of investigational devices, an average of one month]

Clinical breakage [Time Frame: Five uses of investigational devices, an average of one month]

Acceptability [Time Frame: Five uses of investigational device, an average of one month]

Invagination [Time Frame: Five uses of investigational devices, an average of one month]

Slippage [Time Frame: Five uses of investigational devices, an average of one month]

Misdirection [Time Frame: Five uses of investigational devices, an average of one month]

Total breakage [Time Frame: Five uses of investigational devices, an average of one month]

Secondary ID(s)

NMRR-15-333-24953

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Twin Catalyst Sdn. Bhd.