Oral Contraceptive Efficacy and Body Weight - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University National Institutes of Health (NIH) Oregon Clinical and Translational Research Institute
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00662454

Purpose

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.

Condition	Intervention	Phase
Contraception Body Weight	Drug: ethinyl estradiol / levonorgestrel	Phase IV

MedlinePlus related topics: Obesity

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	January 2006
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator 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.
II: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662454

Locations

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

Sponsors and Collaborators

Oregon Health and Science University

National Institutes of Health (NIH)

Oregon Clinical and Translational Research Institute

Investigators

Principal Investigator:

Alison Edelman, MD, MPH

Oregon Health and Science University

More Information

Additional Information:

OHSU Women's Health Research Unit This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Oregon Health & Science University ( Alison Edelman, MD, MPH )
Study ID Numbers:	OHSU FAMPLAN 0411, NIH R03 HD053611 01
Study First Received:	April 16, 2008
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00662454 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

contraceptive
efficacy
body weight

Study placed in the following topic categories:

Obesity
Estrogens
Contraceptive Agents
Benzoates
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Ethinyl Estradiol
Estradiol 17 beta-cypionate
Hormones
Estradiol
Body Weight
Signs and Symptoms
Estradiol 3-benzoate
Levonorgestrel
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Reproductive Control Agents

Hormones
Pharmacologic Actions
Estradiol
Body Weight
Signs and Symptoms
Therapeutic Uses
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on May 07, 2009