Effects of ethinyl estradiol and ibuprofen compared to placebo on endometrial bleeding, cervical mucus and the postcoital test in levonorgestrel subcutaneous implant users

Archer, David F.; Philput, Christine B.; Levine, Adam S.; Cullins, Vanessa; Stovall, Thomas G.; Bacon, Janice; Weber, Margaret E.

doi:10.1016/j.contraception.2008.04.003

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Volume 78, Issue 2 , Pages 106-112, August 2008

Effects of ethinyl estradiol and ibuprofen compared to placebo on endometrial bleeding, cervical mucus and the postcoital test in levonorgestrel subcutaneous implant users☆

David F. Archer
- CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA 23507, USA
- Corresponding author. The CONRAD Clinical Research Center, The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, 601 Colley Avenue, Norfolk, VA 23507-1927, USA. Tel.: +1 757 446 7444; fax: +1 757 446 8998.
Christine B. Philput
- RTTP Inc., Winchendon, MA 01475, USA
Adam S. Levine
- Tampa Obstetrics, Fertility and Gynecology, Brandon, FL 33511, USA
Vanessa Cullins
- Planned Parenthood Federation of America, New York, NY 10001, USA
Thomas G. Stovall
- Women's Health Specialists, Germantown, TN 38138, USA
Janice Bacon
- Department of Obstetrics and Gynecology, University of South Carolina School of Medicine, Columbia, SC 29209, USA
Margaret E. Weber
- Medical Affairs Department of Wyeth Pharmaceuticals, Collegeville, PA 19426, USA

Received 2 February 2008; received in revised form 7 April 2008; accepted 14 April 2008. published online 09 June 2008.

Abstract

Background

The study was conducted to evaluate ethinyl estradiol (EE) or ibuprofen (IBU) compared to placebo (PL) on spotting and bleeding (S/B) and a postcoital test (PCT) in women using the levonorgestrel subcutaneous implant. Women experiencing excessive S/B were enrolled in a multicenter prospective randomized study using EE, IBU or PL.

Outcome Measures

Duration of S/B and a PCT were evaluated. Statistical analysis used a general linear model procedure with Duncan's multiple range tests for individual variables.

Results

One hundred seven women were evaluated, and there was no difference in the duration of bleeding among the three therapies, while the mean number of spotting days were 1.8 for EE and 2.8 for PL (p=.04). There was no effect of IBU on S/B. No effect on cervical mucus or sperm was found between treatments.