Oral Contraceptive Efficacy and Body Weight

NCT00662454 | Completed Phase 4 DMC

• 2 other identifiers: OHSU FAMPLAN 0411NIH R03 HD053611 01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception; Body Weight

Keywords

contraceptive; efficacy; body weight

Outcome Measures

Primary Outcomes (1)

• Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts

  Approximately one year

Study Arms (2)

I

ACTIVE COMPARATOR

10 normal weight women (BMI \< 25 kg/m2)

Drug: ethinyl estradiol / levonorgestrel

II

ACTIVE COMPARATOR

10 obese women (BMI \>30 kg/m2)

Drug: ethinyl estradiol / levonorgestrel

Interventions

ethinyl estradiol / levonorgestrel DRUG

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.

Also known as: Alesse

I

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institutes of Health (NIH): collaborator
• Oregon Clinical and Translational Research Institute: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

• OHSU Women's Health Research Unit

MeSH Terms

Conditions

Body Weight

Interventions

Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: January 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)