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

NCT02593214 | Completed

• 1 other identifier: NMRR-15-333-24953
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Condoms, Female; Contraception, Barrier

Outcome Measures

Primary Outcomes (1)

• Total female condom failure

  Number of times a non-clinical breakage, clinical breakage, or slippage occurs, or that is associated with misdirection, invagination, or any additional failure modes identified in the risk assessment

  Five uses of investigational devices, an average of one month

Secondary Outcomes (10)

• Total clinical failure

  Five uses of investigational devices, an average of one month

• Clinical breakage

  Five uses of investigational devices, an average of one month

• Non-clinical breakage

  Five uses of investigational devices, an average of one month

• Total breakage

  Five uses of investigational devices, an average of one month

• Slippage

  Five uses of investigational devices, an average of one month

Study Arms (1)

Wondaleaf Arm

EXPERIMENTAL

This is a single arm clinical trial, all subjects and their married couples were be recruited to the arm using investigational device Wondaleaf only.

Device: Wondaleaf®

Interventions

Wondaleaf® DEVICE

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

Wondaleaf Arm

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• Twin Catalyst Sdn. Bhd.: collaborator

Study Sites (1)

Sibu Hospital

Sibu, Sarawak, 96000, Malaysia

Location

Related Publications (2)

• Beksinska M, Joanis C, Manning J, Smit J, Callahan M, Deperthes B, Usher-Patel M. Standardized definitions of failure modes for female condoms. Contraception. 2007 Apr;75(4):251-5. doi: 10.1016/j.contraception.2006.10.003. Epub 2007 Feb 7.

  PMID: 17362701 BACKGROUND

• Mitchell HS, Stephens E. Contraception choice for HIV positive women. Sex Transm Infect. 2004 Jun;80(3):167-73. doi: 10.1136/sti.2003.008441.

  PMID: 15169996 BACKGROUND

Related Links

• Reproductive Health Supplies Coalition. Caucus on new and underused reproductive health technologies 2013.

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teck-Hock Toh

  Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

• Loke-Meng Ong

  Clinical Research Centre, Penang General Hospital, Penang State Health Department, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

• Shirin Hui Tan

  Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

• Sing Hong Chuo

  Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 2, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2016-08

Locations

MY (1)