The Stork OTC: Collection, Placement & Delivery

Completed · Not applicable

Conditions studied: Safety and Usability

In brief

This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal

Key facts

Study ID

NCT02038322

Run by

Rinovum Women's Health, Inc.

People needed

53

Starts

2013-07-01

Expected to finish

2014-01-01

Last updated by the study team

2014-01-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Literacy must be in English (able to understand Informed Consent)
• In general good health
• Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active (as a couple)
• 18 - 50 years of age
• REALM-SF Test Results demonstrate 6th grade literacy or above
• Past experience with using condoms
• Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.
• Signed Informed Consent

You may not qualify if…

• Vaginal prolapsed (female)
• Hysterectomy (female)
• Erectile Dysfunction (male)
• Colposcopy with biopsy surgery within the last three (3) months (female)
• Treatment for dysplasia surgery within the last three (3) months (female)
• Vaginal/cervical surgery within the last three (3) months (female)
• Current Pregnancy (female)
• Unable to read and understand English

Where it is running

• Forbes Regional Hospital — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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