Clinical trial NCT00764881: Effects of SH T00658ID on Libido
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Libido
Keywords: Oral contraceptive
Sexual dysfunction
Libido
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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 outcomes:
measure: The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of FSFI Total Score at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of FSFI Total Score at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in FSFI Total Score
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline
timeFrame: At Baseline
measure: The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Vaginal Effects Evaluated by Vaginal pH at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline
timeFrame: At Baseline
measure: Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: 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)
measure: Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline
timeFrame: At Baseline
measure: Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: 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)
measure: Number of Bleeding / Spotting Days in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Bleeding / Spotting Days in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Spotting Only Days in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Spotting Only Days in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Spotting Only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Spotting Only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Mean Length of Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Mean Length of Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Maximum Length of Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Maximum Length of Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1
measure: Onset of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3
measure: Onset of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With at Least 1 Intracyclic Bleeding Episode
timeFrame: Up to Cycle 6 (28 days per Cycle)
Other outcomes:
Locations:
city: Ashfield
country: Australia
facility: Sydney Centre for Reproductive Health Reseach
state: New South Wales
city: Sydney
country: Australia
facility: Royal Hospital for Women
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Queen Elizabeth II Medical Centre
state: Western Australia
city: Subiaco
country: Australia
facility: King Edward Memorial Hospital
state: Western Australia
city: St. Pölten
country: Austria
facility: Ordination Dr. Schmidl-Amann
state: Niederösterreich
city: Graz
country: Austria
facility: Ordination Dr.Hohlweg
state: Steiermark
city: Graz
country: Austria
facility: Ordination Dr. Schaffer
state: Steiermark
city: Wien
country: Austria
facility: Dr. Brigitte Wiesenthal
city: Wien
country: Austria
facility: Clin Pharm International GmbH Studienzentrum Wien
city: Wien
country: Austria
facility: Dr. Wolfgang Bartl
city: Zeltweg
country: Austria
facility: Dr. Walter Paulik
city: Bruxelles - Brussel
country: Belgium
facility: Hôpital Erasme/Erasmus Ziekenhuis
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Frauenarztpraxis Dr. Bernd Pittner
state: Sachsen
city: Hamburg
country: Germany
facility: Praxis Dr. A. Schwenkhagen-Stodieck
city: Monserrato
country: Italy
facility: A.O.U. di Cagliari
state: Cagliari
city: Catania
country: Italy
facility: A.O.U. Policlinico - Vittorio Emanuele
city: Pavia
country: Italy
facility: IRCCS Fondazione Maugeri - Montescano (Pavia)
city: Pisa
country: Italy
facility: A.O.U. Pisana
city: Gava
country: Spain
facility: Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues
state: Barcelona
city: Alicante
country: Spain
facility: Centro de Planificacion Familiar Alicante 3
city: Barcelona
country: Spain
facility: USP Institut Universitari Dexeus
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodhi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.