Trial Outcomes & Findings for Oral Contraceptives and Body Mass Index (NCT NCT01170390)
NCT ID: NCT01170390
Last Updated: 2015-12-31
Results Overview
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
COMPLETED
PHASE4
32 participants
baseline (2 months) and post-randomization (4 months)
2015-12-31
Participant Flow
A prospective cohort study was conducted at the Oregon Health \& Science University (OHSU) in Portland, OR, from March 2006 to September 2007. Recruitment included print ads in local newspapers, flyers posted in the Center for Women's Health \& other OHSU clinics and public places, and electronic postings to web sites such as Craig's List.
Participant milestones
| Measure |
All Participants
All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
|
Study Arm #1 (Aviane and Aviane)
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Study Arm #2 (Aviane and Portia)
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|---|
|
Oral Contraceptives
STARTED
|
32
|
0
|
0
|
|
Oral Contraceptives
COMPLETED
|
31
|
0
|
0
|
|
Oral Contraceptives
NOT COMPLETED
|
1
|
0
|
0
|
|
Randomized Treatment
STARTED
|
0
|
17
|
15
|
|
Randomized Treatment
COMPLETED
|
0
|
16
|
15
|
|
Randomized Treatment
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Contraceptives and Body Mass Index
Baseline characteristics by cohort
| Measure |
Aviane and Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
Total
n=31 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
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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
|
30 years
STANDARD_DEVIATION 4 • n=5 Participants
|
27 years
STANDARD_DEVIATION 4 • n=7 Participants
|
29 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (2 months) and post-randomization (4 months)Population: One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
Outcome measures
| Measure |
Aviane & Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|
|
LNG Steady State at Baseline and Then Post-randomization
After randomization (4 months)
|
3.01 ng/mL
Standard Deviation 0.19
|
3.58 ng/mL
Standard Deviation 0.35
|
|
LNG Steady State at Baseline and Then Post-randomization
LNG steady state levels at baseline
|
3.82 ng/mL
Standard Deviation 1.28
|
3.13 ng/mL
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: post-randomization (4 months)Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.
Outcome measures
| Measure |
Aviane & Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|
|
LNG AUC
|
412 hr*ng/mL
Standard Deviation 255
|
283 hr*ng/mL
Standard Deviation 130
|
SECONDARY outcome
Timeframe: baseline (2 months)Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.
Outcome measures
| Measure |
Aviane & Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|
|
LNG AUC
|
267 hr*ng/mL
Standard Deviation 115
|
199 hr*ng/mL
Standard Deviation 75
|
SECONDARY outcome
Timeframe: Baseline (2 months)Population: One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm
Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
Outcome measures
| Measure |
Aviane & Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|
|
EE Steady State Baseline
|
0.12 ng/mL
Standard Deviation 0.04
|
0.1 ng/mL
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Post-randomiziation 4 monthsSteady state levels of ethinyl estradiol (EE) post- randomization
Outcome measures
| Measure |
Aviane & Aviane
n=16 Participants
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
|
Aviane and Portia
n=15 Participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
|
|---|---|---|
|
EE Steady State After Randomization
|
0.08 ng/mL
Standard Deviation 0.08
|
0.11 ng/mL
Standard Deviation 0.01
|
Adverse Events
Aviane and Aviane
Aviane and Portia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place