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BioMed research international
2015;2015 934164.

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

Sanjay K Agarwal, AnnaMarie Daniels, Steven R Drosman, Laurence Udoff, Warren G Foster, Malcolm C Pike, Darcy V Spicer, John R Daniels
Author Information
  1. Sanjay K Agarwal: Center for Endometriosis Research and Treatment, Department of Reproductive Medicine, UC San Diego, 9500 Gilman Drive, No. 0633, La Jolla, CA 92093-0633, USA.
  2. AnnaMarie Daniels: Balance Pharmaceuticals, 842 N Las Casas Avenue, Pacific Palisades, CA 90272, USA.
  3. Steven R Drosman: Genesis Center for Clinical Research, 3651 4th Avenue, San Diego, CA 92103, USA.
  4. Laurence Udoff: Genetics and IVF Institute, 3015 Williams Drive, Fairfax, VA 22031, USA.
  5. Warren G Foster: Department of Obstetrics and Gynecology, McMaster University, 1280 Main Street West, HSC-3N52D, Hamilton, ON, Canada L8S 4K1.
  6. Malcolm C Pike: Department of Preventive Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
  7. Darcy V Spicer: Division of Medical Oncology, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
  8. John R Daniels: Division of Medical Oncology, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
PMID: 26881208 DOI: 10.1155/2015/934164

Abstract

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.

References

Fertil Steril. 2011 Aug;96(2):360-5 [PMID: 21719000]
Maturitas. 1984 Dec;6(4):351-8 [PMID: 6442755]
J Sex Med. 2012 Apr;9(4):1134-48 [PMID: 22304681]
Bone. 1999 May;24(5):517-23 [PMID: 10321913]
Obstet Gynecol. 2010 Jul;116(1):223-36 [PMID: 20567196]
Fertil Steril. 1995 Sep;64(3):474-81 [PMID: 7641897]
Arch Gynecol Obstet. 2014 Sep;290(3):513-23 [PMID: 24728145]
Reprod Domest Anim. 2014 Oct;49 Suppl 4:64-71 [PMID: 25277434]
Am J Obstet Gynecol. 1998 May;178(5):1087-99 [PMID: 9609589]
Am J Obstet Gynecol. 1994 May;170(5 Pt 1):1213-23 [PMID: 8178840]
Ann Oncol. 2014 Sep;25(9):1719-28 [PMID: 24651411]
Acta Endocrinol (Copenh). 1984 May;106(1):116-20 [PMID: 6730851]
Fertil Steril. 1996 Jun;65(6):1253-5 [PMID: 8641510]
BMJ. 1993 May 29;306(6890):1437-40 [PMID: 8518639]
Climacteric. 2005 Aug;8 Suppl 1:3-63 [PMID: 16112947]
Am J Obstet Gynecol. 1981 Mar 15;139(6):645-54 [PMID: 6452062]
Expert Opin Pharmacother. 2014 Apr;15(6):767-73 [PMID: 24588662]
J Sex Med. 2014 Mar;11(3):831-9 [PMID: 24433574]
J Reprod Med. 1998 Mar;43(3 Suppl):287-92 [PMID: 9564663]
Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):85-9 [PMID: 20832162]
Psychosom Med. 1987 Jul-Aug;49(4):397-409 [PMID: 3615768]
J Clin Endocrinol Metab. 1973 Mar;36(3):475-81 [PMID: 4685386]
J Reprod Med. 1997 Jul;42(7):413-23 [PMID: 9252932]
J Natl Cancer Inst. 1995 Sep 20;87(18):1372-82 [PMID: 7658498]
Fertil Steril. 1999 Mar;71(3):420-4 [PMID: 10065775]
Cochrane Database Syst Rev. 2012 Aug 15;(8):CD000402 [PMID: 22895916]
Fertil Steril. 1994 Jul;62(1):20-7 [PMID: 8005293]
Hum Reprod. 2007 Jan;22(1):266-71 [PMID: 16936305]
Bone. 1995 Aug;17(2):157-9 [PMID: 8554924]
Fertil Steril. 1990 Aug;54(2):227-32 [PMID: 2199228]
J Clin Endocrinol Metab. 1997 Aug;82(8):2386-90 [PMID: 9253305]
Fertil Steril. 2014 Apr;101(4):927-35 [PMID: 24630080]
Cochrane Database Syst Rev. 2014 Mar 10;(3):CD009590 [PMID: 24610050]
Post Reprod Health. 2015 Mar;21(1):16-23 [PMID: 25802141]
J Clin Endocrinol Metab. 1998 Jul;83(7):2266-74 [PMID: 9661593]
J Reprod Med. 1998 Mar;43(3 Suppl):299-308 [PMID: 9564665]
Am J Obstet Gynecol. 1992 Feb;166(2):740-5 [PMID: 1536260]
J Clin Psychopharmacol. 2015 Aug;35(4):389-95 [PMID: 26061609]
Reprod Sci. 2012 Jun;19(6):563-71 [PMID: 22457429]
Obstet Gynecol. 2015 Sep;126(3):617-27 [PMID: 26181088]
N Engl J Med. 2008 Nov 6;359(19):2005-17 [PMID: 18987368]
Lancet. 1987 Feb 7;1(8528):297-9 [PMID: 2880114]
Med Care. 1992 Jun;30(6):473-83 [PMID: 1593914]
Gynecol Obstet Invest. 1999;47(1):37-41 [PMID: 9852390]
Lancet. 1992 Nov 21;340(8830):1267-71 [PMID: 1359330]
JSLS. 2000 Apr-Jun;4(2):97-101 [PMID: 10917114]
Fertil Steril. 1995 Oct;64(4):673-85 [PMID: 7672133]
Mol Psychiatry. 2015 Jun;20(6):695-702 [PMID: 24732671]
Br J Obstet Gynaecol. 1998 May;105(5):475-85 [PMID: 9637115]
Br J Obstet Gynaecol. 1994 May;101 Suppl 10:2-9 [PMID: 8199099]
Obstet Gynecol. 1998 Jan;91(1):16-24 [PMID: 9464714]
Int J Fertil Womens Med. 1997 Nov-Dec;42(6):406-11 [PMID: 9459084]
Obstet Gynecol. 1999 Sep;94(3):330-6 [PMID: 10472854]

MeSH Term

Adult
Endometriosis
Enzyme Inhibitors
Estradiol
Female
Humans
Middle Aged
Testosterone
Triptorelin Pamoate

Chemicals

Enzyme Inhibitors
Triptorelin Pamoate
Testosterone
Estradiol
deslorelin
Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

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