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

This is an interventional prevention trial for Pregnancy focused on measuring Condoms, Female, Contraception, Barrier Read More

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).