Trial Condition(s):

Contraception, Libido

Effects of SH T00658ID on libido

Bayer Identifier:

91548

ClinicalTrials.gov Identifier:

NCT00764881

EudraCT Number:

2008-002263-13

Study Completed

Trial Purpose

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.

Inclusion Criteria
- OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
 - Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline
Exclusion Criteria
- Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

Trial Summary

Enrollment Goal
217
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

Status
Terminated
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95123

Status
Completed
 
Locations

A.O.U. di Cagliari

Monserrato, Italy, 09124

Status
Completed
 
Locations

IRCCS Fondazione Maugeri - Montescano (Pavia)

Pavia, Italy, 27100

Status
Completed
 
Locations

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

Gava, Spain, 08850

Status
Terminated
 
Locations

USP Institut Universitari Dexeus

Barcelona, Spain, 08028

Status
Terminated
 
Locations

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Status
Terminated
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Royal Hospital for Women

Sydney, Australia, 2031

Status
Completed
 
Locations

King Edward Memorial Hospital

Subiaco, Australia, 6008

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

Queen Elizabeth II Medical Centre

Nedlands, Australia, 6009

Status
Completed
 
Locations

Dr. Walter Paulik

Zeltweg, Austria, 8740

Status
Completed
 
Locations

Praxis Dr. A. Schwenkhagen-Stodieck

Hamburg, Germany, 20357

Status
Completed
 
Locations

Universitätsklinikum Aachen

Aachen, Germany, 52074

Status
Terminated
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain, 28009

Status
Completed
 
Locations

Centro de Planificacion Familiar Alicante 3

Alicante, Spain, 03013

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

The Alfred Hospital

Prahran, Australia, 3121

Status
Completed
 
Locations

Sydney Centre for Reproductive Health Reseach

Ashfield, Australia, 2031

Status
Completed
 
Locations

Ordination Dr. Schmidl-Amann

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Dr. Wolfgang Bartl

Wien, Austria, 1200

Status
Completed
 
Locations

Clin Pharm International GmbH Studienzentrum Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Ordination Dr. Schaffer

Graz, Austria, 8044

Status
Completed
 
Locations

Chulalongkorn Hospital

Bangkok , Thailand, 10330

Status
Completed
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand, 10400

Status
Terminated
 
Locations

Ordination Dr.Hohlweg

Graz, Austria, 8010

Status
Completed
 
Locations

Dr. Brigitte Wiesenthal

Wien, Austria, 1070

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 

Trial Design