Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.

Phase 2/3 Completed 103 enrolled Centro A.F. de Estudios Tecnologicos, S.A.

RandomizedParallel-groupSingle-blindTreatment

Summary

During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms

Timeline

Start: 2007-04
Primary completion: 2008-11
Completion: 2008-11

Publications

Cortes-Bonilla M, Alonso-Campero R, Bernardo-Escudero R, Francisco-Doce MT, Chavarin-Gonzalez J, Perez-Cuevas R, Chedraui P. Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17beta-estradiol/progesterone. Gynecol Endocrinol. 2016 Oct;32(10):831-834. doi: 10.1080/09513590.2016.1183628. Epub 2016 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	0.5 mg	Intramuscular
Subject	Estradiol	Other / unclassified	1 mg	Intramuscular
Subject	Progesterone	Other / unclassified	15 mg	Intramuscular
Subject	Progesterone	Other / unclassified	20 mg	Intramuscular
Subject	Progesterone	Other / unclassified	30 mg	Intramuscular

Indications

No indication recorded.