The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant
NCT ID: NCT01855620
Last Updated: 2014-04-14
Study Results
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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COMPLETED
52 participants
OBSERVATIONAL
2012-12-31
2014-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal weight women
Women with implant for more than twelve months who have BMI \<25.
No interventions assigned to this group
Overweight women
Women with implant for more than twelve months who have BMI \> or = 25 and \<30.
No interventions assigned to this group
Obese women
Women with implant for more than twelve months who have BMI \> or = 30.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* English or Spanish-speaking
Exclusion Criteria
FEMALE
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Kathleen M. Morrell
Assistant Professor of Clinical Obgyn
Principal Investigators
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Kathleen M Morrell, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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References
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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.
Ciangura C, Corigliano N, Basdevant A, Mouly S, Decleves 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.
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. doi: 10.1016/0010-7824(93)90042-6.
Diaz 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. doi: 10.1016/0010-7824(91)90030-j.
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.
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.
Huber J, Wenzl R. RETRACTED: Pharmacokinetics of Implanon. An integrated analysis. Contraception. 1998 Dec;58(6 Suppl):85S-90S. doi: 10.1016/s0010-7824(98)00120-6.
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.
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.
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. doi: 10.1016/s0010-7824(01)00226-8.
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.
Morrell KM, Cremers S, Westhoff CL, Davis AR. Relationship between etonogestrel level and BMI in women using the contraceptive implant for more than 1 year. Contraception. 2016 Mar;93(3):263-5. doi: 10.1016/j.contraception.2015.11.005. Epub 2015 Nov 11.
Related Links
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Nexplanon Prescribing information
Other Identifiers
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AAAK6606
Identifier Type: -
Identifier Source: org_study_id
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