Effects of SH T00658ID on Libido

NCT00764881 | Completed Phase 3 Results

• 3 other identifiers: 915482008-002263-13310785
• Study Type: interventional
• Target: 217
• Locations: 6 countries
• Sites: 25

Brief 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.

Conditions

Contraception; Libido

Keywords

Oral contraceptive; Sexual dysfunction; Libido

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)

  Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

  Baseline up to Cycle 6 (28 days per Cycle)

• Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)

  Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

  Baseline up to Cycle 6 (28 days per Cycle)

Secondary Outcomes (108)

• The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline

  At Baseline

• The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6

  At Cycle 6 (28 days per Cycle)

• Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)

  Baseline up to Cycle 6 (28 days per Cycle)

• The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline

  At Baseline

• The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6

  At Cycle 6 (28 days per Cycle)

Study Arms (2)

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

EXPERIMENTAL

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.

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

EE/LNG (Microgynon) + Placebo

ACTIVE COMPARATOR

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.

Drug: Microgynon; Drug: Placebo

Interventions

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

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

Microgynon 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.

EE/LNG (Microgynon) + Placebo

Placebo DRUG

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

EE/LNG (Microgynon) + Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (32)

Sydney Centre for Reproductive Health Reseach

Ashfield, New South Wales, 2031, Australia

Location

Royal Hospital for Women

Sydney, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3121, Australia

Location

Queen Elizabeth II Medical Centre

Nedlands, Western Australia, 6009, Australia

Location

King Edward Memorial Hospital

Subiaco, Western Australia, 6008, Australia

Location

Ordination Dr. Schmidl-Amann

Sankt Pölten, Lower Austria, 3100, Austria

Location

Ordination Dr.Hohlweg

Graz, Styria, 8010, Austria

Location

Ordination Dr. Schaffer

Graz, Styria, 8044, Austria

Location

Clin Pharm International GmbH Studienzentrum Wien

Vienna, Vienna, 1090, Austria

Location

Dr. Brigitte Wiesenthal

Vienna, 1070, Austria

Location

Dr. Wolfgang Bartl

Vienna, 1200, Austria

Location

Dr. Walter Paulik

Zeltweg, 8740, Austria

Location

Hôpital Erasme/Erasmus Ziekenhuis

Bruxelles - Brussel, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Praxis Dr. A. Schwenkhagen-Stodieck

Hamburg, Hamburg, 20357, Germany

Location

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, 04207, Germany

Location

A.O.U. di Cagliari

Monserrato, Cagliari, 09124, Italy

Location

A.O.U. Policlinico - Vittorio Emanuele

Catania, 95123, Italy

Location

IRCCS Fondazione Maugeri - Montescano (Pavia)

Pavia, 27100, Italy

Location

A.O.U. Pisana

Pisa, 56126, Italy

Location

Centro de Planificacion Familiar Alicante 3

Alicante, Alicante, 03013, Spain

Location

USP Institut Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues

Gavà, Barcelona, 08850, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 28009, Spain

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Ramathibodhi Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital, Mahidol

Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 24034466 DERIVED

Related Links

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

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

ethinyl estradiol, levonorgestrel drug combination

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 30, 2014
• Results First Posted: April 3, 2012

Record last verified: 2014-12

Locations

TH (3); IT (4); BE (3); AU (6); DE (4); ES (5)