NCT01564940

Brief Summary

The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

March 25, 2012

Last Update Submit

March 27, 2012

Conditions

Cervical Cap Insemination

Keywords

Cervical cap inseminationUsability Study

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Females between the ages of 20 and 45.

You may qualify if:

  • Female, any ethnicity
  • years of age
  • Sexually active
  • Signed Informed Consent

You may not qualify if:

  • Prior surgery to the cervix or vaginal tract
  • Vaginal prolapse
  • Cervical cancer
  • Hysterectomy
  • History of Toxic Shock Syndrome (TSS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Location

Study Officials

  • Michael J Pelekanos, OB-GYN

    Forbes Regional Hospital (West Penn Allegheny Health System)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2012

First Posted

March 28, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(1)