The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant

Obesity Clinical Trial

— Eto BMI  

Official title:

The Effect of Body Mass Index on Etonogestrel Levels in Women Using the Single-rod Contraceptive Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855620
• Other study ID #: AAAK6606
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: April 11, 2014
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Two-thirds of young women in the United States are overweight or obese. This excess weight may affect how their body metabolizes drugs such as different birth control methods. There is a not a lot of research about how excess weight could affect the hormone levels of the contraceptive implant. Methods like the implant contain only progesterone, which is a hormone that does not increase a woman's risk of blood clot. These methods would be preferred for overweight and obese women because excess weight also increases a woman's risk of blood clot.

The investigators propose a study comparing blood hormone levels of women using the implant for at least twelve months and in all weight categories. The investigators hope to show that all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.

Description:

Two-thirds of reproductive-age women in the United States are either overweight or obese. Body composition may affect contraceptive hormone metabolism and possibly efficacy. Phase III studies to date included few women weighing more than 70 kilograms (134 of 923, 14.5%); there were no reported pregnancies in that group. Data about pregnancy rates for women in higher body mass index (BMI) categories using the etonogestrel implant exists, but we know little about how weight affects the serum etonogestrel levels. Progestin-only methods, such as the etonogestrel implant, may be preferred over combined methods including estrogens because obesity increases thrombosis risk.

The investigators propose a prospective study to compare serum etonogestrel levels in the second and third years of implant use between women across body mass index categories.

Based on previous studies, the investigators expect a difference in etonogestrel levels based on body weight; however, the investigators hypothesize that etonogestrel levels will remain above the threshold for ovulation suppression through three years of implant use for women across BMI categories.

The investigators will measure the serum levels of etonogestrel in normal weight (BMI < 25kg/m2), overweight (BMI ≥ 25kg/m2 and < 30kg/m2), and obese women (BMI ≥ 30kg/m2) using the single-rod contraceptive implant for at least twelve months. Their primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/mL) (Díaz 1991) in any group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Woman using contraceptive implant for more than 12 months

• English or Spanish-speaking

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception
• Obesity

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Ciangura C, Corigliano N, Basdevant A, Mouly S, Declèves X, Touraine P, Lloret-Linares C. Etonorgestrel concentrations in morbidly obese women following Roux-en-Y gastric bypass surgery: three case reports. Contraception. 2011 Dec;84(6):649-51. doi: 10.1016/j.contraception.2011.03.015. Epub 2011 May 8. — View Citation

Davies GC, Feng LX, Newton JR, Van Beek A, Coelingh-Bennink HJ. Release characteristics, ovarian activity and menstrual bleeding pattern with a single contraceptive implant releasing 3-ketodesogestrel. Contraception. 1993 Mar;47(3):251-61. — View Citation

Díaz S, Pavez M, Moo-Young AJ, Bardin CW, Croxatto HB. Clinical trial with 3-keto-desogestrel subdermal implants. Contraception. 1991 Oct;44(4):393-408. — View Citation

Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17. — View Citation

Graesslin O, Korver T. The contraceptive efficacy of Implanon: a review of clinical trials and marketing experience. Eur J Contracept Reprod Health Care. 2008 Jun;13 Suppl 1:4-12. doi: 10.1080/13625180801942754. Review. — View Citation

Huber J, Wenzl R. Pharmacokinetics of Implanon. An integrated analysis. Contraception. 1998 Dec;58(6 Suppl):85S-90S. Erratum in: Contraception 1999 Feb;59(2):145. Retraction in: Rekers H, Affandi B. Contraception. 2004 Nov;70(5):433. — View Citation

Jacobson JC, Aikins Murphy P. United States medical eligibility criteria for contraceptive use 2010: a review of changes. J Midwifery Womens Health. 2011 Nov-Dec;56(6):598-607. doi: 10.1111/j.1542-2011.2011.00093.x. Epub 2011 Oct 17. Review. — View Citation

Mornar S, Chan LN, Mistretta S, Neustadt A, Martins S, Gilliam M. Pharmacokinetics of the etonogestrel contraceptive implant in obese women. Am J Obstet Gynecol. 2012 Aug;207(2):110.e1-6. doi: 10.1016/j.ajog.2012.05.002. Epub 2012 May 8. — View Citation

Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000. — View Citation

Sivin I, Wan L, Ranta S, Alvarez F, Brache V, Mishell DR Jr, Darney P, Biswas A, Diaz S, Kiriwat O, Anant MP, Klaisle C, Pavez M, Schechter J. Levonorgestrel concentrations during 7 years of continuous use of Jadelle contraceptive implants. Contraception. 2001 Jul;64(1):43-9. — View Citation

Xu H, Wade JA, Peipert JF, Zhao Q, Madden T, Secura GM. Contraceptive failure rates of etonogestrel subdermal implants in overweight and obese women. Obstet Gynecol. 2012 Jul;120(1):21-6. doi: 10.1097/AOG.0b013e318259565a. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Etonogestrel Level	The investigators will measure the serum levels of etonogestrel in normal weight (BMI < 25kg/m2), overweight (BMI = 25kg/m2 and < 30kg/m2), and obese women (BMI = 30kg/m2) using the single-rod contraceptive implant for at least twelve months. The primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/mL) (Díaz 1991) in any group.	Up to 12 months	No

External Links

•   Nexplanon Prescribing information