Oral Contraceptive Efficacy and Body Weight

Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.

Study Overview

• Status: Completed
• Conditions: Body Weight; Contraception
• Intervention / Treatment: Drug: ethinyl estradiol / levonorgestrel

Detailed Description

The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age 18 to 35
• single baseline hematocrit ≥ 36%
• single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.

Exclusion Criteria:

• any absolute contraindications to ethinyl estradiol and levonorgestrel
• smoking
• actively seeking or involved in a weight loss program (must be weight stable)
• pregnancy, breastfeeding, or seeking pregnancy
• diagnosis of Polycystic Ovarian Syndrome
• recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
• DepoProvera use within six months
• current use of drugs that interfere with metabolism of sex steroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I; 10 normal weight women (BMI < 25 kg/m2)	Drug: ethinyl estradiol / levonorgestrel; Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.; Other Names: Alesse
Active Comparator: II; 10 obese women (BMI >30 kg/m2)	Drug: ethinyl estradiol / levonorgestrel; Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.; Other Names: Alesse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts	Approximately one year

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institutes of Health (NIH); Oregon Clinical and Translational Research Institute
• Investigators: Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University

Publications and helpful links

Helpful Links

• OHSU Women's Health Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: efficacy; body weight; contraceptive
• Additional Relevant MeSH Terms: Body Weight; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Ethinyl Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Ethinyl estradiol, levonorgestrel drug combination
• Other Study ID Numbers: OHSU FAMPLAN 0411; NIH R03 HD053611 01