NCT00764881 - Effects of SH T00658ID on Libido | Biotech Hunter

Enrollment

217

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions

ContraceptionLibido

Interventions

DRUG

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose

DRUG

Microgynon

Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.

DRUG

Placebo

Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Trial Locations (32)

1070

Dr. Brigitte Wiesenthal, Vienna

Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles - Brussel

1090

Clin Pharm International GmbH Studienzentrum Wien, Vienna

1200

Dr. Wolfgang Bartl, Vienna

2031

Sydney Centre for Reproductive Health Reseach, Ashfield

Royal Hospital for Women, Sydney

3000

UZ Leuven Gasthuisberg, Leuven

3100

Ordination Dr. Schmidl-Amann, Sankt Pölten

3121

The Alfred Hospital, Prahran

5000

Royal Adelaide Hospital, Adelaide

6008

King Edward Memorial Hospital, Subiaco

6009

Queen Elizabeth II Medical Centre, Nedlands

8010

Ordination Dr.Hohlweg, Graz

8044

Ordination Dr. Schaffer, Graz

8740

Dr. Walter Paulik, Zeltweg

9000

UZ Gent, Ghent

10330

Chulalongkorn Hospital, Bangkok

10400

Ramathibodhi Hospital, Bangkok

10700

Siriraj Hospital, Mahidol, Bangkok

18014

Hospital Universitario Virgen de las Nieves, Granada

20357

Praxis Dr. A. Schwenkhagen-Stodieck, Hamburg

27100

IRCCS Fondazione Maugeri - Montescano (Pavia), Pavia

28009

Instituto Palacios de Salud y Medicina de la Mujer, Madrid

52074

Universitätsklinikum Aachen, Aachen

56126

A.O.U. Pisana, Pisa

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

95123

A.O.U. Policlinico - Vittorio Emanuele, Catania

04207

Frauenarztpraxis Dr. Bernd Pittner, Leipzig

09124

A.O.U. di Cagliari, Monserrato

03013

Centro de Planificacion Familiar Alicante 3, Alicante

08028

USP Institut Universitari Dexeus, Barcelona

08850

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues, Gavà