Pharmacokinetics of Implanon in Obese Women

Obesity Clinical Trial

Official title:

Pharmacokinetics of Implanon in Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724438
• Other study ID #: 15956A
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 4, 2013
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• premenopausal with a uterus and at least one ovary

• willing and able to sign the informed consent

• willing to comply with the study protocol and visit schedule

• have a body mass index of less than 25, or greater than or equal to 30

• weight stable

Exclusion Criteria:

• known or suspected pregnancy

• delivery (vaginal or cesarean) within 4 months of device insertion

• abortion (first or second trimester) within 4 months of device insertion

• contraindications to Implanon use

• hemophilia

• undiagnosed abnormal genital bleeding

• hypersensitivity or allergy to any components of Implanon

• personal or family history of thrombosis or thromboembolic disorders

• hepatic tumors or active liver disease

• known or suspected carcinoma of the breast or history of breast cancer

• more that one cardiovascular risk factor such as hypertension or diabetes

• known history of PCOS, diabetes, or glucose abnormality

• present use or use within 2 months of device insertion of a CYP3A4 inducer

• breastfeeding women

• use of an investigational drug within 2 months of device insertion

• use of injectable contraception within 6 months of device insertion

• planning a pregnancy in the next 12 months

• known HIV infection

• smoking over the age of 35

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception
• Obesity

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.		6 months	No
Secondary	To describe ease of insertion and palpation of Implanon among obese women		6 months	No
Secondary	To describe bleeding patterns among obese users of Implanon		6 months	No
Secondary	To describe the acceptability of Implanon among obese women		6 months	No
Secondary	To describe the discontinuation rates, reason for discontinuation, and ease of removal in obese women who discontinue the device before or at the end of the 6 month study period		6 months	No
Secondary	To determine whether etonogestrel levels can be obtained from finger-stick blood spots		6 months	No

External Links

•   University of Chicago Section of Family Planning and Contraceptive Research