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Obesity and Oral Contraceptive Failure

NCT ID: NCT01944306

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-04-30

Brief Summary

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Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. Further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women.

The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. The main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure.

Reproductive-aged, ovulatory women of obese BMI \>30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (\<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.

Detailed Description

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Conditions

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Contraception Fetal Growth Retardation Infant, Small for Gestational Age Obesity

Keywords

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Pharmacokinetics Pharmacology, Clinical Drug Efficacy Drug Failure Contraceptive Agents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low birth-weight, obese

No interventions assigned to this group

Low birth-weight, normal body weight

No interventions assigned to this group

Normal birth-weight, obese

No interventions assigned to this group

Normal birth-weight, normal body weight

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 18 to 35.
* single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to dosing with oral contraceptives.

Exclusion Criteria

* absolute/relative contraindications to ethinyl estradiol and levonorgestrel.
* impaired liver function.
* history of deep venous thrombosis.
* hypertension (\> 140/90).
* diabetes with vascular changes.
* migraines with aura or neurological changes.
* history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
* anemia (hematocrit \< 36%).
* actively seeking or involved in a weight loss program (must be weight stable)
* pregnancy, breastfeeding, or seeking pregnancy.
* diagnosis of Polycystic Ovarian Syndrome.
* recent (4 week) use of hormonal contraceptives (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.
* smokers.
* uncontrolled thyroid dysfunction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ganesh Cherala, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Edelman AB, Carlson NE, Cherala G, Munar MY, Stouffer RL, Cameron JL, Stanczyk FZ, Jensen JT. Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity. Contraception. 2009 Aug;80(2):119-27. doi: 10.1016/j.contraception.2009.04.011. Epub 2009 Jun 4.

Reference Type BACKGROUND
PMID: 19631786 (View on PubMed)

Cherala G, Thornburg K, Edelman A. Birthweight and cytochrome P4503A4/5 activity in obese women. Br J Clin Pharmacol. 2013 Jan;75(1):275-6. doi: 10.1111/j.1365-2125.2012.04309.x. No abstract available.

Reference Type BACKGROUND
PMID: 22534035 (View on PubMed)

Edelman AB, Cherala G, Munar MY, Dubois B, McInnis M, Stanczyk FZ, Jensen JT. Prolonged monitoring of ethinyl estradiol and levonorgestrel levels confirms an altered pharmacokinetic profile in obese oral contraceptives users. Contraception. 2013 Feb;87(2):220-6. doi: 10.1016/j.contraception.2012.10.008. Epub 2012 Nov 12.

Reference Type BACKGROUND
PMID: 23153898 (View on PubMed)

Edelman A, Cherala G, Lim JY, Jensen JT. Contraceptive failures in overweight and obese combined hormonal contraceptive users. Obstet Gynecol. 2013 Jul;122(1):158-159. doi: 10.1097/AOG.0b013e3182995811. No abstract available.

Reference Type BACKGROUND
PMID: 23787930 (View on PubMed)

Other Identifiers

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2K12HD043488-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00009569

Identifier Type: -

Identifier Source: org_study_id