MedDataX Logo

Effects of SH T00658ID on Libido

NCT ID: NCT00764881

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Libido

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oral contraceptive Sexual dysfunction Libido

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

EE/LNG (Microgynon) + Placebo

Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.

Group Type ACTIVE_COMPARATOR

Microgynon

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sydney Centre for Reproductive Health Reseach

Ashfield, New South Wales, Australia

Site Status

Royal Hospital for Women

Sydney, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Prahran, Victoria, Australia

Site Status

Queen Elizabeth II Medical Centre

Nedlands, Western Australia, Australia

Site Status

King Edward Memorial Hospital

Subiaco, Western Australia, Australia

Site Status

Ordination Dr. Schmidl-Amann

Sankt Pölten, Lower Austria, Austria

Site Status

Ordination Dr.Hohlweg

Graz, Styria, Austria

Site Status

Ordination Dr. Schaffer

Graz, Styria, Austria

Site Status

Clin Pharm International GmbH Studienzentrum Wien

Vienna, Vienna, Austria

Site Status

Dr. Brigitte Wiesenthal

Vienna, , Austria

Site Status

Dr. Wolfgang Bartl

Vienna, , Austria

Site Status

Dr. Walter Paulik

Zeltweg, , Austria

Site Status

Hôpital Erasme/Erasmus Ziekenhuis

Bruxelles - Brussel, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Praxis Dr. A. Schwenkhagen-Stodieck

Hamburg, City state of Hamburg, Germany

Site Status

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, Germany

Site Status

A.O.U. di Cagliari

Monserrato, Cagliari, Italy

Site Status

A.O.U. Policlinico - Vittorio Emanuele

Catania, , Italy

Site Status

IRCCS Fondazione Maugeri - Montescano (Pavia)

Pavia, , Italy

Site Status

A.O.U. Pisana

Pisa, , Italy

Site Status

Centro de Planificacion Familiar Alicante 3

Alicante, Alicante, Spain

Site Status

USP Institut Universitari Dexeus

Barcelona, Barcelona, Spain

Site Status

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

Gavà, Barcelona, Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, , Spain

Site Status

Chulalongkorn Hospital

Bangkok, , Thailand

Site Status

Ramathibodhi Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital, Mahidol

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Austria Belgium Germany Italy Spain Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24034466 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-002263-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310785

Identifier Type: OTHER

Identifier Source: secondary_id

91548

Identifier Type: -

Identifier Source: org_study_id