Oral Contraceptive Efficacy and Body Weight

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662454
• Other study ID #: OHSU FAMPLAN 0411
• Secondary ID: NIH R03 HD053611
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: May 2006

Study information

• Verified date: September 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Contraception

Intervention

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.
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institutes of Health (NIH), Oregon Clinical and Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts		Approximately one year

External Links

•   OHSU Women's Health Research Unit