Trials Sponsors Conditions Drugs Pricing

Conditions

Pregnancy Sexually Transmitted Disease

Keywords

Condoms, FemaleContraception, 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
+5 more secondary outcomes

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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;

Sponsors & Collaborators

Twin Catalyst Sdn Bhd
Industrycollaborator
Clinical Research Centre, Malaysia
Otherlead

Study Sites (1)

Sibu Hospital

Sibu, Sarawak, 96000, Malaysia

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: 17362701BACKGROUND
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: 15169996BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological 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

Enrollment

21 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

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;
+1 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Wondaleaf Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Wondaleaf Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations