Oral Contraceptives and Body Mass Index

This study has been completed.

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Alison Edelman, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01170390

First received: October 27, 2009

Last updated: November 25, 2015

Last verified: November 2015

History of Changes

Results First Received: May 7, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Conditions:	Body Weight Contraceptive Usage
Interventions:	Drug: All participants (Aviane) Drug: Portia Drug: Aviane

Participant Flow

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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

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

Baseline Characteristics

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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
Number of Participants [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

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Alison Edelman
Organization: Oregon Health & Science University
phone: 503.418.2585
e-mail: edelmana@ohsu.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Edelman AB, Cherala G, Munar MY, McInnis M, Stanczyk FZ, Jensen JT. Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial. Contraception. 2014 Nov;90(5):550-6. doi: 10.1016/j.contraception.2014.06.033. Epub 2014 Jun 27.

Responsible Party:	Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01170390 History of Changes
Other Study ID Numbers:	OHSU FAMPLAN 5382 R01HD061582 ( US NIH Grant/Contract Award Number )
Study First Received:	October 27, 2009
Results First Received:	May 7, 2014
Last Updated:	November 25, 2015
Health Authority:	United States: Institutional Review Board

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