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

October 27, 2009
November 25, 2015
September 2009
March 2011   (final data collection date for primary outcome measure)
LNG Steady State at Baseline and Then Post-randomization [ Time Frame: baseline (2 months) and post-randomization (4 months) ] [ Designated as safety issue: No ]
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
To determine if alternative dosing regimens result in improved pharmacokinetic parameters and ovarian suppression and similar safety biomarkers in obese women. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01170390 on ClinicalTrials.gov Archive Site
  • LNG AUC [ Time Frame: post-randomization (4 months) ] [ Designated as safety issue: No ]
    Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.
  • LNG AUC [ Time Frame: baseline (2 months) ] [ Designated as safety issue: No ]
    Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.
  • EE Steady State Baseline [ Time Frame: Baseline (2 months) ] [ Designated as safety issue: No ]
    Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
  • EE Steady State After Randomization [ Time Frame: Post-randomiziation 4 months ] [ Designated as safety issue: No ]
    Steady state levels of ethinyl estradiol (EE) post- randomization
To confirm obesity-related differences in the pharmacokinetics of orally-dosed combined hormonal contraceptives. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Oral Contraceptives and Body Mass Index
Improving Contraceptive Effectiveness in Obese Women
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.

This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Body Weight
  • Contraceptive Usage
  • Drug: All participants (Aviane)
    20 mcg EE/0.1 mg LNG cyclically
    Other Name: Levonorgestrel and Ethinyl Estradiol
  • Drug: Portia
    30 mcg EE/0.15 mg LNG cyclically
    Other Name: Levonorgestrel and Ethinyl Estradiol
  • Drug: Aviane
    20 mcg EE/0.1 mg LNG continuously dosed
    Other Name: Levonorgestrel and Ethinyl Estradiol
  • 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).
    Intervention: Drug: All participants (Aviane)
  • Active Comparator: 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
    Intervention: Drug: Portia
  • Active Comparator: 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)
    Intervention: Drug: Aviane
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2011
March 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170390
OHSU FAMPLAN 5382, R01HD061582
Yes
Not Provided
Not Provided
Alison Edelman, Oregon Health and Science University
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
Oregon Health and Science University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP