Correcting oral contraceptive pharmacokinetic alterations due to obesity: A randomized controlled trial

Alison Edelman, Ganesh Cherala, Myrna Y. Munar, Martha McInnis, Frank Z. Stanczyk, Jeffrey Jensen

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objective: To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic (PK) alterations caused by obesity during oral contraceptive (OC) use. Study design: Obese [body mass index (BMI)≥30 kg/m2], ovulatory, otherwise healthy, women received an OC containing 20 mcg ethinyl estradiol (EE)/100 mcg levonorgestrel (LNG) dosed cyclically (21 days active pills with 7-day placebo week) for two cycles and then were randomized for two additional cycles to the following: continuous cycling (CC, a dose neutral arm using the same OC with no hormone-free interval) or increased dose (ID, a dose escalation arm using an OC containing 30 mcg EE/150 mcg LNG cyclically). During Cycles 2, 3 and 4, outpatient visits were performed to assess maximum serum concentration (Cmax), area under the curve (AUC0-∞) and time to steady state as well as pharmacodynamics. These key PK parameters were calculated and compared within groups between baseline and treatment cycles. Results: A total of 31 women enrolled and completed the study (CC group, n=16; ID group, n=15). Demographics were similar between groups [mean BMI: CC, 38 kg/m2 (S.D. 5.1); ID, 41 kg/m2 (S.D. 7.6)]. At baseline, the key LNG PK parameters were no different between groups; average time to reach steady state was 12 days in both groups; Cmax were CC: 3.82±1.28 ng/mL and ID: 3.13±0.87 ng/mL; and AUC0-∞ were CC: 267±115 h ng/mL and ID: 199±75 h ng/mL. Following randomization, the CC group maintained steady-state serum levels whereas the ID group had a significantly higher Cmax (p

Original languageEnglish (US)
Pages (from-to)550-556
Number of pages7
JournalContraception
Volume90
Issue number5
DOIs
StatePublished - Nov 1 2014

Fingerprint

Oral Contraceptives
Levonorgestrel
Randomized Controlled Trials
Pharmacokinetics
Obesity
Ethinyl Estradiol
Hormones
Body Mass Index
Random Allocation
Serum
Area Under Curve
Outpatients
Placebos
Demography
Therapeutics

Keywords

  • BMI
  • Continuous dosing
  • Drug levels
  • Hormonal contraception

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Medicine(all)

Cite this

Correcting oral contraceptive pharmacokinetic alterations due to obesity : A randomized controlled trial. / Edelman, Alison; Cherala, Ganesh; Munar, Myrna Y.; McInnis, Martha; Stanczyk, Frank Z.; Jensen, Jeffrey.

In: Contraception, Vol. 90, No. 5, 01.11.2014, p. 550-556.

Research output: Contribution to journalArticle

Edelman, Alison ; Cherala, Ganesh ; Munar, Myrna Y. ; McInnis, Martha ; Stanczyk, Frank Z. ; Jensen, Jeffrey. / Correcting oral contraceptive pharmacokinetic alterations due to obesity : A randomized controlled trial. In: Contraception. 2014 ; Vol. 90, No. 5. pp. 550-556.
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