Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2009-09-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Reproductive-aged, ovulatory women of obese (BMI \>30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All 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).
All participants (Aviane)
20 mcg EE/0.1 mg LNG cyclically
Aviane and Portia
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
Portia
30 mcg EE/0.15 mg LNG cyclically
Aviane & Aviane
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
20 mcg EE/0.1 mg LNG continuously dosed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
All participants (Aviane)
20 mcg EE/0.1 mg LNG cyclically
Portia
30 mcg EE/0.15 mg LNG cyclically
Aviane
20 mcg EE/0.1 mg LNG continuously dosed
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI \> 30kg/m2
* Proof of a normal breast and pelvic exam within last 9 months
* Self reported normal menstrual periods (24-35 days)
* Good general health
* In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
* Single progesterone level during screening visit ≥ 3ng/mL
* Hematocrit ≥ 36%
Exclusion Criteria
* Smoker (must smoke 0 cigarettes)
* Actively seeking/involved in a weight loss program
* Currently pregnant/seeking pregnancy in the next 6 months
* Currently breast-feeding
* Past or current diagnosis of polycystic ovarian disease
* Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
* Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alison Edelman
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alison Edelman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health and Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
(OHSU Women's Health Research Unit)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OHSU FAMPLAN 5382
Identifier Type: -
Identifier Source: org_study_id