check_circleStudy Completed

Contraception, Libido

Bayer Identifier:

91548

ClinicalTrials.gov Identifier:

NCT00764881

EudraCT Number:

2008-002263-13

EU CT Number:

Not Available
Effects of SH T00658ID on libido

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - 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
  • - 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
January 2009 - July 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
A.O.U. Policlinico - Vittorio EmanueleCatania, 95123, Italy
Completed
A.O.U. di CagliariMonserrato, 09124, Italy
Completed
IRCCS Fondazione Maugeri - Montescano (Pavia)Pavia, 27100, Italy
Terminated
Diatros Gava- Centre Assistencial Ntra. Sra. de BurguesGava, 08850, Spain
Terminated
USP Institut Universitari DexeusBarcelona, 08028, Spain
Terminated
Hospital Universitario Virgen de las NievesGranada, 18014, Spain
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Completed
Royal Hospital for WomenSydney, 2031, Australia
Completed
King Edward Memorial HospitalSubiaco, 6008, Australia
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Queen Elizabeth II Medical CentreNedlands, 6009, Australia
Completed
Dr. Walter PaulikZeltweg, 8740, Austria
Completed
Praxis Dr. A. Schwenkhagen-StodieckHamburg, 20357, Germany
Terminated
Universitätsklinikum AachenAachen, 52074, Germany
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
Instituto Palacios de Salud y Medicina de la MujerMadrid, 28009, Spain
Completed
Centro de Planificacion Familiar Alicante 3Alicante, 03013, Spain
Completed
UZ GentGENT, 9000, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
The Alfred HospitalPrahran, 3121, Australia
Completed
Sydney Centre for Reproductive Health ReseachAshfield, 2031, Australia
Completed
Ordination Dr. Schmidl-AmannSt. Pölten, 3100, Austria
Completed
Dr. Wolfgang BartlWien, 1200, Austria
Completed
Clin Pharm International GmbH Studienzentrum WienWien, 1090, Austria
Completed
Ordination Dr. SchafferGraz, 8044, Austria
Completed
Chulalongkorn HospitalBangkok, 10330, Thailand
Terminated
Ramathibodhi HospitalBangkok, 10400, Thailand
Completed
Ordination Dr.HohlwegGraz, 8010, Austria
Completed
Dr. Brigitte WiesenthalWien, 1070, Austria
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand

Primary Outcome

  • 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)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The mean absolute values of FSFI domain score (desire) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (desire) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (desire)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (arousal) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (arousal) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (arousal)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (lubrication) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (lubrication) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (lubrication)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (orgasm) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (orgasm) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (orgasm)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (satisfaction) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (satisfaction) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (satisfaction)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (pain) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI domain score (pain) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI domain score (pain)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI total score at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of FSFI total score at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in FSFI total score
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Female Sexual Distress Scale (FSDS-R) total score at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Female Sexual Distress Scale (FSDS-R) total score at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) total score
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total score at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total score at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total score
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) global score at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) global score at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) global score
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – anxiety at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – anxiety at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – anxiety
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – depressed mood at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – depressed mood at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – depressed mood
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – positive well-being at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – positive well-being at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – positive well-being
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – self-control at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – self-control at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – self-control
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – general health at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – general health at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – general health
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – vitality at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The mean absolute values of Psychological General Well-Being Index (PGWBI) – vitality at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – vitality
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in participant's assessment in Clinical Global Impression (CGI) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by vaginal pH at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean absolute values of Atrophy Symptom Questionnaire (ASQ) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean absolute values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean change from Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean absolute values of Vaginal Health Assessment (VHA) at Baseline
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean absolute values of Vaginal Health Assessment (VHA) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal effects evaluated by the mean change from Baseline to Cycle 6 in Vaginal Health Assessment (VHA)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting days in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting days in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting only days in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting only days in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with at least 1 intracyclic bleeding episode
    date_rangeTime Frame:
    Up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Multi-center, double-blind, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (Microgynon) over 6 treatment cycles on alleviating complaints of reduced libido in women with acquired female sexual dysfunction (FSD) associated with oral contraceptive use
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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