Does the Selective Progesterone Receptor Modulator Ulipristal Normalize the Uterine Cavity in Women with Leiomyoma?
|Gary Levy*, Nilo Avila, Alicia Armstrong and Lynette Nieman|
|National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Program in Reproductive and Adult Endocrinology, 10 Center Drive, Bldg 10, CRC, Rm 1-3140, Bethesda, MD 20892, USA|
|*Corresponding Author :||Dr. Gary Levy
10 Center Drive, Bldg 10, CRC
Rm 1-3140, Bethesda, MD 20892, USA
E-mail: [email protected]
|Received November 12, 2011; Accepted December 09, 2011; Published December 12, 2011|
|Citation: Levy G, Avila N, Armstrong A, Nieman L (2011) Does the Selective Progesterone Receptor Modulator Ulipristal Normalize the Uterine Cavity in Women with Leiomyoma? J Fertiliz In Vitro 1:102. doi:10.4172/2165-7491.1000102|
|Copyright: © 2011 Levy G, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
Objective: To determine if three months of chronic daily administration of ulipristal acetate (UPA), a selective progesterone receptor modulator, normalized the uterine cavity in women with leiomyoma.
Methods: Saline sonograms with abnormal uterine cavities from patients participating in a placebo controlled double blind randomized controlled trial evaluating UPA effect on leiomyoma volume were identified prior to initiation of therapy. They were reexamined after 12 weeks of UPA therapy. Normal uterine cavity was defined as having zero percent of leiomyoma volume inside the cavity on repeat sonohysterography. Patients with normal saline sonograms after 12 weeks of UPA therapy were compared with patients with sonographically persistently abnormal uterine cavities. Statistical analysis was performed using the Fisher’s exact test.
Results: 28 patients had abnormal sonohysterogram results at baseline (n= 9, n= 8 and n=11 for placebo, UPA 10 mg and UPA 20 mg respectively). At the end of treatment 22% of the placebo group, 38% of the 10 mg group and 27% of the 20 mg group had normal uterine cavities. When the 10 mg and 20 mg groups were combined, 32% of the patients had normal uterine cavities post treatment. The results did not reach statistical significance.
Conclusion: If future larger, randomized trials demonstrate a benefit, UPA may offer an alternative to surgical therapy for women requiring normalization of the uterine cavity.