Trial Outcomes & Findings for Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® (NCT NCT00710606)

Results Overview

Serum concentrations were obtained from thirty-seven women completed follow-up.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Measurements at Week 3 and Week 6 continuous ring use

Results posted on

2015-04-30

Participant Flow

Subjects were enrolled during the months of June-September 2008.

Participant milestones

Participant milestones
Measure	Obese Subjects Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.	Normal Weight Subjects Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Obese Subjects Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.	Normal Weight Subjects Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Overall Study Adverse Event	0	2

Baseline Characteristics

Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Subjects n=20 Participants Obese subjects (BMI 30-39.9)	Normal Weight Subjects n=20 Participants Normal weight subjects (BMI 19-24.9)	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	24.5 years STANDARD_DEVIATION 3.2 • n=5 Participants	26.0 years STANDARD_DEVIATION 3.6 • n=7 Participants	25.8 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Measurements at Week 3 and Week 6 continuous ring use

Population: 17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.

Serum concentrations were obtained from thirty-seven women completed follow-up.

Outcome measures

Outcome measures
Measure	Normal Weight n=18 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.	Obese n=19 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol Etonogesterel (ENG) Week 3	1275 ng/L Interval 1116.0 to 1457.0	1240 ng/L Interval 1041.0 to 1477.0
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol Ethinyl Estradiol (EE) Week 3	21.9 ng/L Interval 17.9 to 26.6	14.8 ng/L Interval 12.7 to 17.3
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol Etonogesterel (ENG) Week 6	1063 ng/L Interval 730.0 to 1548.0	1096 ng/L Interval 730.0 to 1646.0
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol Ethinyl Estradiol (EE) Week 6	16.2 ng/L Interval 10.1 to 25.8	12.5 ng/L Interval 8.1 to 19.5

SECONDARY outcome

Timeframe: continuous ring use, an average of 3 weeks

Population: 17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.

Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter \> 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).

Outcome measures

Outcome measures
Measure	Normal Weight n=19 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.	Obese n=18 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up	2 Participant w/follicular diameter >=13mm	3 Participant w/follicular diameter >=13mm

SECONDARY outcome

Timeframe: Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks

Population: 17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.

The mean endometrial proliferation from week 1, week 2 and week3

Outcome measures

Outcome measures
Measure	Normal Weight n=19 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.	Obese n=18 Participants Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Mean Endometrial Proliferation	4.7 millimeters Standard Deviation 1.8	3.9 millimeters Standard Deviation 1.6

Adverse Events

Obese Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Weight Subjects

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Obese Subjects n=20 participants at risk Obese subjects (BMI 30-39.9)	Normal Weight Subjects n=20 participants at risk Normal weight subjects (BMI 19-24.9)
Musculoskeletal and connective tissue disorders fractured pelvis	0.00% 0/20 • 3 months	5.0% 1/20 • Number of events 1 • 3 months
Vascular disorders venous thrombosis	0.00% 0/20 • 3 months	5.0% 1/20 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Westhoff

Columbia University

Phone: 212-305-4805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place