Oral Contraceptives and Body Mass Index

Body Weight Clinical Trial

Official title:

Improving Contraceptive Effectiveness in Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170390
• Other study ID #: OHSU FAMPLAN 5382
• Secondary ID: R01HD061582
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2009
• Last updated: November 25, 2015
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Weight
• Contraceptive Usage

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	LNG AUC	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.	post-randomization (4 months)	No
Secondary	LNG AUC	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.	baseline (2 months)	No
Secondary	EE Steady State Baseline	Steady state levels of ethinyl estradiol (EE) at baseline (2 months)	Baseline (2 months)	No
Secondary	EE Steady State After Randomization	Steady state levels of ethinyl estradiol (EE) post- randomization	Post-randomiziation 4 months	No