Trial Outcomes & Findings for Hormonal Contraception and Vaginal Health (NCT NCT00612508)

NCT ID: NCT00612508

Last Updated: 2012-11-08

Results Overview

Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: baseline, 84 days, 168 days
• Results posted on: 2012-11-08

Participant Flow

Participant milestones

Measure	Desogen oral contraceptive	NuvaRing intravaginal contraception
Overall Study STARTED	7	7
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Desogen oral contraceptive	NuvaRing intravaginal contraception
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

Hormonal Contraception and Vaginal Health

Baseline characteristics by cohort

Measure	Desogen n=7 Participants oral contraceptive	NuvaRing n=7 Participants intravaginal contraception	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	28 years STANDARD_DEVIATION 4 • n=5 Participants	24 years STANDARD_DEVIATION 3.4 • n=7 Participants	25.8 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 84 days, 168 days

Population: A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days). The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)

Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days

Outcome measures

Measure	Desogen n=5 Participants oral contraceptive = P (pill)	NuvaRing n=6 Participants intravaginal contraception = R (ring)
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. mean difference at 84 days	0.01 mm Standard Deviation 0.06	-0.005 mm Standard Deviation 0.048
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. mean difference at 168 days	-0.02 mm Standard Deviation 0.09	.007 mm Standard Deviation 0.028

SECONDARY outcome

Timeframe: over 168 days

Population: All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event

Self-reported treatment-related and serious adverse events

Outcome measures

Measure	Desogen n=7 Participants oral contraceptive = P (pill)	NuvaRing n=7 Participants intravaginal contraception = R (ring)
Adverse Events	1 participants	0 participants

Adverse Events

Desogen

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

NuvaRing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Desogen n=7 participants at risk oral contraceptive	NuvaRing n=7 participants at risk intravaginal contraception
Reproductive system and breast disorders Bleeding from vagina	14.3% 1/7 • Number of events 1 • Every 6 months	0.00% 0/7 • Every 6 months

Additional Information

Oregon Health & Science University

Women's Health Research Unit

Phone: 503-494-3666

Email: whru@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place