Oral Contraceptives and Body Mass Index

NCT01170390 | Completed Phase 4 Results DMC

• 2 other identifiers: OHSU FAMPLAN 5382R01HD061582
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Weight; Contraceptive Usage

Keywords

Obesity; Body weight; Oral contraception; Efficacy

Outcome Measures

Primary Outcomes (1)

• LNG Steady State at Baseline and Then Post-randomization

  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).

  baseline (2 months) and post-randomization (4 months)

Secondary Outcomes (4)

• LNG AUC

  post-randomization (4 months)

• LNG AUC

  baseline (2 months)

• EE Steady State Baseline

  Baseline (2 months)

• EE Steady State After Randomization

  Post-randomiziation 4 months

Study Arms (3)

All participants

OTHER

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).

Drug: All participants (Aviane)

Aviane and Portia

ACTIVE COMPARATOR

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

Drug: Portia

Aviane & Aviane

ACTIVE COMPARATOR

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)

Drug: Aviane

Interventions

All participants (Aviane) DRUG

20 mcg EE/0.1 mg LNG cyclically

Also known as: Levonorgestrel and Ethinyl Estradiol

All participants

Portia DRUG

30 mcg EE/0.15 mg LNG cyclically

Also known as: Levonorgestrel and Ethinyl Estradiol

Aviane and Portia

Aviane DRUG

20 mcg EE/0.1 mg LNG continuously dosed

Also known as: Levonorgestrel and Ethinyl Estradiol

Aviane & Aviane

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 25070547 DERIVED

Related Links

• (OHSU Women's Health Research Unit)

MeSH Terms

Conditions

Body Weight; Contraception Behavior; Obesity

Interventions

ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Reproductive Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Alison Edelman
• Organization: Oregon Health & Science University

edelmana@ohsu.edu

503.418.2585

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: July 27, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 31, 2015
• Results First Posted: November 26, 2015

Record last verified: 2015-11

Locations

US (1)