Effects of SH T00658ID on Libido

Phase 3 Completed 217 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Timeline

Start: 2009-01
Primary completion: 2010-07
Completion: 2010-07

Publications

Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, Mellinger U, Nappi RE. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013 Dec;10(12):3069-79. doi: 10.1111/jsm.12310. Epub 2013 Sep 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	3 mg	Oral
Comparator	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	estradiol valerate	Unknown	2 mg	Oral
Comparator	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.