Safety and Acceptability Study of a Non-Hormonal Ring
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03598088|
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : June 8, 2022
Last Update Posted : June 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Device: Ovaprene||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Safety and Acceptability Study of a Non-Hormonal Ring|
|Actual Study Start Date :||May 23, 2018|
|Actual Primary Completion Date :||October 17, 2019|
|Actual Study Completion Date :||November 15, 2019|
Healthy Sexually Active Women
Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene and the Caya diaphragm throughout the course of the trial. The purpose of the Caya Post Coital Test (PCT) cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated.
non-hormonal contraceptive ring
- Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. [ Time Frame: Baseline to OVP PCTa at 175 Days ]All participants had fewer than 5 progressively motile sperm per high power field (PMS/HPF) in all cycles during Ovaprene use.
- Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device. [ Time Frame: Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs) ]Evaluating the change in CVF pH before and after sex with no device present.
- Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. [ Time Frame: OVP Cycle A Visit 13 (Day 121) to Visit 14 (Day 122) and OVP Cycle B Visit 18 (Day 156) to Visit 19 (Day 157). ]Evaluating the change in CVF pH before and after intercourse when the Ovaprene device was being worn during intercourse.
- Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device. [ Time Frame: 175 days ]Number of participants within the Ovaprene population that experienced a Urogenital treatment emergent adverse event (AE).
- Number of Participants With Changes in Pelvic Exam Findings From Baseline [ Time Frame: 175 days ]Pelvic exams were completed at all 21 visits via a vaginal Colposcopy procedure.
- Changes From Baseline in Nugent Score [ Time Frame: 175 days ]
Nugent scores were calculated prior to the insertion of each Ovaprene device and then after the device was removed at the end of each cycle.
Nugent score is a gram stain storage system assessing vaginal bacteria present on a scale of 0-10. Scores ranging from 7-10 are indicative of bacterial vaginosis.
- Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. [ Time Frame: Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157). ]Measuring the E.coli inhibition (%) pre and post intercourse
- Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. [ Time Frame: Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157). ]Measurement of Interleukin-1 Beta (pg IL-1Beta/ug Protein), Interleukin-8 (pg IL-8/ug Protein), Secretory leukocyte Peptidase Inhibitor (SLPI)
- Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device. [ Time Frame: 35 days (one complete cycle) ]Vaginal samples and swabs of the used Ovaprene devices were tested for growth of staphylococcus aureus.
- Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle. [ Time Frame: 35 days (one full cyle) ]Vaginal samples and swabs of the used Ovaprene devices were tested for group A Streptococcus.
- Summary of the Acceptability of the Study Device Among Male and Female Participants. [ Time Frame: 175 days ]Summary of Open-Ended Acceptability Questionnaire
- Participants Who Could be Fitted With the Ovaprene Device [ Time Frame: Screening or BP3 Visit (2 days) ]
- Participants That Could Correctly Insert, Position and Remove the Ovaprene Device [ Time Frame: Visit 3 (BP3, Day 15-20); Visit 7 (OS1, Day 84); Visit 12 (OP1a, Day 112); Visit 13 (OP2a, Day 122-132); Visit 17 (OP1b, Day 140); UNS could occur at any point during the 175 day study duration ]Number of participants that required written instructions, those who required written and verbal instructions and those who needed physical assistance.
- Location of Ovaprene in Relation to Cervix [ Time Frame: 175 days ]Location was determined digitally and visually by the investigators.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598088
|United States, California|
|University of California at Davis|
|Sacramento, California, United States, 95817|
|United States, Florida|
|North Miami, Florida, United States, 33161|
|United States, Idaho|
|Clinical Research Prime|
|Idaho Falls, Idaho, United States, 83404|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania Penn Obstetric Gynecology Associates|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Nadene A. Zack, MS||Sr Director, Clinical Operations|