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
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
No text entered.

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  



  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.
No text entered.

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
  Show All Outcome Measures

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 ]


  Serious Adverse Events


  Other Adverse Events


  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):

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