Phase 4 N=32 Randomized Diagnostic

Oral Contraceptives and Body Mass Index

Body Weight · Contraceptive Usage

Bottom Line

View on ClinicalTrials.gov: NCT01170390 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: LNG Steady State at Baseline and Then Post-randomization — 3.82; 3.13; 3.01; 3.58 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: All participants (Aviane) (Drug); Portia (Drug); Aviane (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY LNG Steady State at Baseline and Then Post-randomization	3.82; 3.13; 3.01; 3.58	—
SECONDARY LNG AUC	267; 199	—
SECONDARY LNG AUC	267; 199	—
SECONDARY EE Steady State Baseline	0.12; 0.1	—
SECONDARY EE Steady State After Randomization	0.08; 0.11	—

Summary

The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.

Eligibility Criteria

Inclusion Criteria

Age 18-35
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

Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01170390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.