NCT01223313 is a NA clinical trial of Woman's Condom in Contraception, sponsored by Premier Research.

Who is sponsoring NCT01223313?

NCT01223313 is sponsored by Premier Research.

What drugs are being tested in NCT01223313?

Interventions in NCT01223313: Woman's Condom.

What condition does NCT01223313 study?

NCT01223313 studies Contraception.

Is NCT01223313 still recruiting?

NCT01223313 is currently completed. Last updated 21 January 2026.

Are results published for NCT01223313?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-21 · How we verify

NCT01223313

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom

Completed NA Results posted Last updated 21 January 2026

What this trial tests

NA trial testing Woman's Condom in Contraception in 511 participants. Completed in 1 September 2015.

Timeline

1 January 2011

Primary endpoint
1 November 2012

1 September 2015

Quick facts

Lead sponsor	Premier Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	511
Start date	1 January 2011
Primary completion	1 November 2012
Estimated completion	1 September 2015
Sites	10 locations across United States

Drugs / interventions tested

Woman's Condom

Conditions studied

Contraception — all drugs for Contraception →

Sponsor

Premier Research — full company profile →

Who can join

Adults 18 to 40, female only, with Contraception. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

6 Month Pregnancy Probabilities With Typical Use
Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
Kaplan-Meier methods will be used to estimate the six-month cumulative pregnancy probability of women in the MITT population. Pregnancies are not included if they are found to have occurred before a subject was enrolled or after she has discontinued using the study product as her primary method of contraception. The pregnancy probability is reported as a percentage.
6 Month Pearl Rate With Typical Use
Time frame: 6 Months
Pearl rate will be calculated based on the number of woman-months that the subject was at risk for pregnancy. Woman-months of pregnancy risk is defined as the (last date study product considered primary means of contraception - date of enrollment + 1) / 30.4 for women who are not pregnant and as (date of conception - date of enrollment + 1) / 30.4 for women who became pregnant during the study.

Sponsor's own description

WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost. WHY IS THIS STUDY BEING DONE? The purpose of this study is to find out: * How well the female condom works to prevent pregnancy * How well the female condom works to prevent transmission of sexually transmitted diseases * How safe the female condom is to use * If urinary tract infections and symptomatic vaginal infections occur while using the female condom * How well women like the female condom * How well the female condom performs. WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation. HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Acceptability of the Woman's Condom in a phase III multicenter open-label study.
Chen BA, Blithe DL, Muraguri GR, Lance AA, et al · · 2019 · cited 3× · PMID 30849305 · DOI 10.1016/j.contraception.2019.02.006

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Premier Research trials

Trials by the same sponsor.

NCT07222228 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception · Phase 2 · not yet recruiting
NCT04143659 — A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception · Phase 1 · active not recruiting
NCT03452111 — Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception · Phase 2 · completed
NCT03455075 — Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men · Phase 2 · completed
NCT03432416 — Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01223313 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Premier Research
Last refreshed: 21 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01223313.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing