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BioMed Research International
Volume 2015, Article ID 934164, 9 pages
Research Article

Treatment of Endometriosis with the GnRHa Deslorelin and Add-Back Estradiol and Supplementary Testosterone

1Center for Endometriosis Research and Treatment, Department of Reproductive Medicine, UC San Diego, 9500 Gilman Drive, No. 0633, La Jolla, CA 92093-0633, USA
2Balance Pharmaceuticals, 842 N Las Casas Avenue, Pacific Palisades, CA 90272, USA
3Genesis Center for Clinical Research, 3651 4th Avenue, San Diego, CA 92103, USA
4Genetics and IVF Institute, 3015 Williams Drive, Fairfax, VA 22031, USA
5Department of Obstetrics and Gynecology, McMaster University, 1280 Main Street West, HSC-3N52D, Hamilton, ON, Canada L8S 4K1
6Department of Preventive Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA
7Division of Medical Oncology, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA

Received 30 September 2015; Accepted 16 December 2015

Academic Editor: Seiichi Saito

Copyright © 2015 Sanjay K. Agarwal et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background. This randomized, multicenter, open-label clinical trial was intended to generate pilot data on the efficacy and safety of the gonadotropin-releasing hormone agonist (GnRHa) deslorelin (D) with low-dose estradiol ± testosterone (E2  ± T) add-back for endometriosis-related pelvic pain. Methods. Women with pelvic pain and laparoscopically confirmed endometriosis were treated with a six-month course of daily intranasal D with concurrent administration of either transdermal E2, intranasal E2, or intranasal E2  + T. Efficacy data included evaluation of dyspareunia, dysmenorrhea, pelvic pain, tenderness, and induration. Cognition and quality of life were also assessed. Safety parameters included assessment of endometrial hyperplasia, bone mineral density (BMD), and hot flashes. Results. Endometriosis symptoms and signs scores decreased in all treatment arms from a baseline average of 7.4 to 2.5 after 3 months of treatment and 3.4 after 6 months. BMD changes and incidence of hot flashes were minimal, and no endometrial hyperplasia was observed. Patient-reported outcomes showed significant improvement across multiple domains. Conclusions. Daily intranasal D with low dose E2  ± T add-back resulted in significant reduction in severity of endometriosis symptoms and signs with few safety signals and minimal hypoestrogenic symptoms that would be expected with the use of a GnRHa alone.