Oral Contraceptives and Body Mass Index

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow for 2 periods

Period 1:   Oral Contraceptives

	All Participants	Study Arm #1 (Aviane and Aviane)	Study Arm #2 (Aviane and Portia)
STARTED	32	0	0
COMPLETED	31	0	0
NOT COMPLETED	1	0	0

Period 2:   Randomized Treatment

	All Participants	Study Arm #1 (Aviane and Aviane)	Study Arm #2 (Aviane and Portia)
STARTED	0	17	15
COMPLETED	0	16	15
NOT COMPLETED	0	1	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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)
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
Total	Total of all reporting groups

Baseline Measures

	Aviane and Aviane	Aviane and Portia	Total
Overall Participants Analyzed  [Units: Participants]	16	15	31
Age  [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	16	15	31
>=65 years	0	0	0
Age  [Units: Years] Mean (Standard Deviation)	30  (4)	27  (4)	29  (4.7)
Gender  [Units: Participants]
Female	16	15	31
Male	0	0	0
Region of Enrollment  [Units: Participants]
United States	16	15	31

1.  Primary:

LNG Steady State at Baseline and Then Post-randomization   [ Time Frame: baseline (2 months) and post-randomization (4 months) ]

2.  Secondary:

LNG AUC   [ Time Frame: post-randomization (4 months) ]

3.  Secondary:

LNG AUC   [ Time Frame: baseline (2 months) ]

4.  Secondary:

EE Steady State Baseline   [ Time Frame: Baseline (2 months) ]

5.  Secondary:

EE Steady State After Randomization   [ Time Frame: Post-randomiziation 4 months ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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