Trial Condition(s):

Contraception, Libido

Effects of SH T00658ID on libido

Bayer Identifier:

91548

ClinicalTrials.gov Identifier:

NCT00764881

EudraCT Number:

2008-002263-13

EU CT Number:

Not Available

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
Locations
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

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Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

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A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95123

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A.O.U. di Cagliari

Monserrato, Italy, 09124

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IRCCS Fondazione Maugeri - Montescano (Pavia)

Pavia, Italy, 27100

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Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

Gava, Spain, 08850

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USP Institut Universitari Dexeus

Barcelona, Spain, 08028

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Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

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Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

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Royal Hospital for Women

Sydney, Australia, 2031

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King Edward Memorial Hospital

Subiaco, Australia, 6008

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Royal Adelaide Hospital

Adelaide, Australia, 5000

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Queen Elizabeth II Medical Centre

Nedlands, Australia, 6009

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Dr. Walter Paulik

Zeltweg, Austria, 8740

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Praxis Dr. A. Schwenkhagen-Stodieck

Hamburg, Germany, 20357

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Universitätsklinikum Aachen

Aachen, Germany, 52074

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A.O.U. Pisana

Pisa, Italy, 56126

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Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain, 28009

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Centro de Planificacion Familiar Alicante 3

Alicante, Spain, 03013

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UZ Gent

GENT, Belgium, 9000

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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The Alfred Hospital

Prahran, Australia, 3121

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Sydney Centre for Reproductive Health Reseach

Ashfield, Australia, 2031

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Ordination Dr. Schmidl-Amann

St. Pölten, Austria, 3100

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Dr. Wolfgang Bartl

Wien, Austria, 1200

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Clin Pharm International GmbH Studienzentrum Wien

Wien, Austria, 1090

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Ordination Dr. Schaffer

Graz, Austria, 8044

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Chulalongkorn Hospital

Bangkok , Thailand, 10330

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Ramathibodhi Hospital

Bangkok, Thailand, 10400

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Ordination Dr.Hohlweg

Graz, Austria, 8010

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Dr. Brigitte Wiesenthal

Wien, Austria, 1070

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Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Trial Design