Trial Condition(s):
Contraception, Libido
Effects of SH T00658ID on libido
Bayer Identifier:
91548
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsklinikum Freiburg Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico - Vittorio Emanuele Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Cagliari Monserrato, Italy, 09124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Maugeri - Montescano (Pavia) Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues Gava, Spain, 08850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations USP Institut Universitari Dexeus Barcelona, Spain, 08028 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen de las Nieves Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hospital for Women Sydney, Australia, 2031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Edward Memorial Hospital Subiaco, Australia, 6008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Medical Centre Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Walter Paulik Zeltweg, Austria, 8740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. A. Schwenkhagen-Stodieck Hamburg, Germany, 20357 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Aachen Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Palacios de Salud y Medicina de la Mujer Madrid, Spain, 28009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Planificacion Familiar Alicante 3 Alicante, Spain, 03013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Alfred Hospital Prahran, Australia, 3121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sydney Centre for Reproductive Health Reseach Ashfield, Australia, 2031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr. Schmidl-Amann St. Pölten, Austria, 3100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Wolfgang Bartl Wien, Austria, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clin Pharm International GmbH Studienzentrum Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr. Schaffer Graz, Austria, 8044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chulalongkorn Hospital Bangkok , Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ramathibodhi Hospital Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr.Hohlweg Graz, Austria, 8010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Brigitte Wiesenthal Wien, Austria, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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)Timeframe: 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)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
Secondary Outcome
- The mean absolute values of FSFI domain score (desire) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (desire) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (desire)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI domain score (arousal) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (arousal) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (arousal)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI domain score (lubrication) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (lubrication) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (lubrication)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI domain score (orgasm) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (orgasm) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (orgasm)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI domain score (satisfaction) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (satisfaction) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (satisfaction)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI domain score (pain) at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI domain score (pain) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI domain score (pain)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of FSFI total score at BaselineTimeframe: At Baseline
- The mean absolute values of FSFI total score at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in FSFI total scoreTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Female Sexual Distress Scale (FSDS-R) total score at BaselineTimeframe: At Baseline
- The mean absolute values of Female Sexual Distress Scale (FSDS-R) total score at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) total scoreTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total score at BaselineTimeframe: At Baseline
- The mean absolute values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total score at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (short version) total scoreTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) global score at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) global score at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) global scoreTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – anxiety at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – anxiety at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – anxietyTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – depressed mood at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – depressed mood at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – depressed moodTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – positive well-being at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – positive well-being at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – positive well-beingTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – self-control at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – self-control at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – self-controlTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – general health at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – general health at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – general healthTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – vitality at BaselineTimeframe: At Baseline
- The mean absolute values of Psychological General Well-Being Index (PGWBI) – vitality at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – vitalityTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with improvement in participant's assessment in Clinical Global Impression (CGI) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Vaginal effects evaluated by vaginal pH at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Vaginal effects evaluated by the mean absolute values of Atrophy Symptom Questionnaire (ASQ) at BaselineTimeframe: At Baseline
- Vaginal effects evaluated by the mean absolute values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Vaginal effects evaluated by the mean change from Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Vaginal effects evaluated by the mean absolute values of Vaginal Health Assessment (VHA) at BaselineTimeframe: At Baseline
- Vaginal effects evaluated by the mean absolute values of Vaginal Health Assessment (VHA) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Vaginal effects evaluated by the mean change from Baseline to Cycle 6 in Vaginal Health Assessment (VHA)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Number of bleeding / spotting days in reference period 1Timeframe: From Day 1 to Day 90
- Number of bleeding / spotting days in reference period 2Timeframe: From Day 91 to Day 180
- Number of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Number of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Mean length of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Mean length of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Maximum length of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Maximum length of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Number of spotting only days in reference period 1Timeframe: From Day 1 to Day 90
- Number of spotting only days in reference period 2Timeframe: From Day 91 to Day 180
- Number of spotting only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Number of spotting only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Mean length of spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Mean length of spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Maximum length of spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Maximum length of spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Difference in duration between longest and shortest spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Difference in duration between longest and shortest spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Percentage of participants with / without withdrawal bleeding at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants with / without withdrawal bleeding at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants with / without withdrawal bleeding at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants by maximum intensity of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Onset of withdrawal bleeding episodes at Cycle 1Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1
- Onset of withdrawal bleeding episodes at Cycle 3Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3
- Onset of withdrawal bleeding episodes at Cycle 6Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with at least 1 intracyclic bleeding episodeTimeframe: Up to Cycle 6 (28 days per Cycle)
Additional Information
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