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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00764881

Registration number

NCT00764881

Ethics application status

Date submitted

1/10/2008

Date registered

2/10/2008

Date last updated

30/12/2014

Titles & IDs

Public title

Effects of SH T00658ID on Libido

Scientific 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

Secondary ID [1]

2008-002263-13

Secondary ID [2]

91548

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Contraception

Libido

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Treatment: Drugs - Microgynon
Treatment: Drugs - Placebo

Experimental: 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.

Active comparator: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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.

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

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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)

Timepoint [1]

Baseline up to Cycle 6 (28 days per Cycle)

Primary outcome [2]

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)

Timepoint [2]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [1]

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

Timepoint [1]

At Baseline

Secondary outcome [2]

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

Timepoint [2]

At Cycle 6 (28 days per Cycle)

Secondary outcome [3]

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

Timepoint [3]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [4]

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

Timepoint [4]

At Baseline

Secondary outcome [5]

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

Timepoint [5]

At Cycle 6 (28 days per Cycle)

Secondary outcome [6]

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

Timepoint [6]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [7]

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

Timepoint [7]

At Baseline

Secondary outcome [8]

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

Timepoint [8]

At Cycle 6 (28 days per Cycle)

Secondary outcome [9]

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

Timepoint [9]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [10]

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

Timepoint [10]

At Baseline

Secondary outcome [11]

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

Timepoint [11]

At Cycle 6 (28 days per Cycle)

Secondary outcome [12]

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

Timepoint [12]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [13]

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

Timepoint [13]

At Baseline

Secondary outcome [14]

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

Timepoint [14]

At Cycle 6 (28 days per Cycle)

Secondary outcome [15]

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

Timepoint [15]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [16]

The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.

Timepoint [16]

At Baseline

Secondary outcome [17]

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

Timepoint [17]

At Cycle 6 (28 days per Cycle)

Secondary outcome [18]

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

Timepoint [18]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [19]

The Mean Absolute Values of FSFI Total Score at Baseline

Timepoint [19]

At Baseline

Secondary outcome [20]

The Mean Absolute Values of FSFI Total Score at Cycle 6

Timepoint [20]

At Cycle 6 (28 days per Cycle)

Secondary outcome [21]

Mean Change From Baseline to Cycle 6 in FSFI Total Score

Timepoint [21]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [22]

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline

Timepoint [22]

At Baseline

Secondary outcome [23]

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6

Timepoint [23]

At Cycle 6 (28 days per Cycle)

Secondary outcome [24]

Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score

Timepoint [24]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [25]

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline

Timepoint [25]

At Baseline

Secondary outcome [26]

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6

Timepoint [26]

At Cycle 6 (28 days per Cycle)

Secondary outcome [27]

Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score

Timepoint [27]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [28]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline

Timepoint [28]

At Baseline

Secondary outcome [29]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6

Timepoint [29]

At Cycle 6 (28 days per Cycle)

Secondary outcome [30]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score

Timepoint [30]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [31]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline

Timepoint [31]

At Baseline

Secondary outcome [32]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6

Timepoint [32]

At Cycle 6 (28 days per Cycle)

Secondary outcome [33]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety

Timepoint [33]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [34]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline

Timepoint [34]

At Baseline

Secondary outcome [35]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6

Timepoint [35]

At Cycle 6 (28 days per Cycle)

Secondary outcome [36]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood

Timepoint [36]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [37]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline

Timepoint [37]

At Baseline

Secondary outcome [38]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6

Timepoint [38]

At Cycle 6 (28 days per Cycle)

Secondary outcome [39]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being

Timepoint [39]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [40]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline

Timepoint [40]

At Baseline

Secondary outcome [41]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6

Timepoint [41]

At Cycle 6 (28 days per Cycle)

Secondary outcome [42]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control

Timepoint [42]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [43]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline

Timepoint [43]

At Baseline

Secondary outcome [44]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6

Timepoint [44]

At Cycle 6 (28 days per Cycle)

Secondary outcome [45]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health

Timepoint [45]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [46]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline

Timepoint [46]

At Baseline

Secondary outcome [47]

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6

Timepoint [47]

At Cycle 6 (28 days per Cycle)

Secondary outcome [48]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality

Timepoint [48]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [49]

Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6

Timepoint [49]

At Cycle 6 (28 days per Cycle)

Secondary outcome [50]

Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6

Timepoint [50]

At Cycle 6 (28 days per Cycle)

Secondary outcome [51]

Vaginal Effects Evaluated by Vaginal pH at Cycle 6

Timepoint [51]

At Cycle 6 (28 days per Cycle)

Secondary outcome [52]

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline

Timepoint [52]

At Baseline

Secondary outcome [53]

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6

Timepoint [53]

At Cycle 6 (28 days per Cycle)

Secondary outcome [54]

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)

Timepoint [54]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [55]

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline

Timepoint [55]

At Baseline

Secondary outcome [56]

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6

Timepoint [56]

At Cycle 6 (28 days per Cycle)

Secondary outcome [57]

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)

Timepoint [57]

Baseline up to Cycle 6 (28 days per Cycle)

Secondary outcome [58]

Number of Bleeding / Spotting Days in Reference Period 1

Timepoint [58]

From Day 1 to Day 90

Secondary outcome [59]

Number of Bleeding / Spotting Days in Reference Period 2

Timepoint [59]

From Day 91 to Day 180

Secondary outcome [60]

Number of Bleeding / Spotting Episodes in Reference Period 1

Timepoint [60]

From Day 1 to Day 90

Secondary outcome [61]

Number of Bleeding / Spotting Episodes in Reference Period 2

Timepoint [61]

From Day 91 to Day 180

Secondary outcome [62]

Mean Length of Bleeding / Spotting Episodes in Reference Period 1

Timepoint [62]

From Day 1 to Day 90

Secondary outcome [63]

Mean Length of Bleeding / Spotting Episodes in Reference Period 2

Timepoint [63]

From Day 91 to Day 180

Secondary outcome [64]

Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

Timepoint [64]

From Day 1 to Day 90

Secondary outcome [65]

Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

Timepoint [65]

From Day 91 to Day 180

Secondary outcome [66]

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

Timepoint [66]

From Day 1 to Day 90

Secondary outcome [67]

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

Timepoint [67]

From Day 91 to Day 180

Secondary outcome [68]

Number of Spotting Only Days in Reference Period 1

Timepoint [68]

From Day 1 to Day 90

Secondary outcome [69]

Number of Spotting Only Days in Reference Period 2

Timepoint [69]

From Day 91 to Day 180

Secondary outcome [70]

Number of Spotting Only Episodes in Reference Period 1

Timepoint [70]

From Day 1 to Day 90

Secondary outcome [71]

Number of Spotting Only Episodes in Reference Period 2

Timepoint [71]

From Day 91 to Day 180

Secondary outcome [72]

Mean Length of Spotting-only Episodes in Reference Period 1

Timepoint [72]

From Day 1 to Day 90

Secondary outcome [73]

Mean Length of Spotting-only Episodes in Reference Period 2

Timepoint [73]

From Day 91 to Day 180

Secondary outcome [74]

Maximum Length of Spotting-only Episodes in Reference Period 1

Timepoint [74]

From Day 1 to Day 90

Secondary outcome [75]

Maximum Length of Spotting-only Episodes in Reference Period 2

Timepoint [75]

From Day 91 to Day 180

Secondary outcome [76]

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

Timepoint [76]

From Day 1 to Day 90

Secondary outcome [77]

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

Timepoint [77]

From Day 91 to Day 180

Secondary outcome [78]

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1

Timepoint [78]

At Cycle 1 (28 days per Cycle)

Secondary outcome [79]

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3

Timepoint [79]

At Cycle 3 (28 days per Cycle)

Secondary outcome [80]

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6

Timepoint [80]

At Cycle 6 (28 days per Cycle)

Secondary outcome [81]

Length of Withdrawal Bleeding Episodes at Cycle 1

Timepoint [81]

At Cycle 1 (28 days per Cycle)

Secondary outcome [82]

Length of Withdrawal Bleeding Episodes at Cycle 3

Timepoint [82]

At Cycle 3 (28 days per Cycle)

Secondary outcome [83]

Length of Withdrawal Bleeding Episodes at Cycle 6

Timepoint [83]

At Cycle 6 (28 days per Cycle)

Secondary outcome [84]

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Timepoint [84]

At Cycle 1 (28 days per Cycle)

Secondary outcome [85]

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Timepoint [85]

At Cycle 3 (28 days per Cycle)

Secondary outcome [86]

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Timepoint [86]

At Cycle 6 (28 days per Cycle)

Secondary outcome [87]

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Timepoint [87]

At Cycle 1 (28 days per Cycle)

Secondary outcome [88]

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Timepoint [88]

At Cycle 3 (28 days per Cycle)

Secondary outcome [89]

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Timepoint [89]

At Cycle 6 (28 days per Cycle)

Secondary outcome [90]

Onset of Withdrawal Bleeding Episodes at Cycle 1

Timepoint [90]

From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1

Secondary outcome [91]

Onset of Withdrawal Bleeding Episodes at Cycle 3

Timepoint [91]

From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3

Secondary outcome [92]

Onset of Withdrawal Bleeding Episodes at Cycle 6

Timepoint [92]

From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6

Secondary outcome [93]

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1

Timepoint [93]

At Cycle 1 (28 days per Cycle)

Secondary outcome [94]

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3

Timepoint [94]

At Cycle 3 (28 days per Cycle)

Secondary outcome [95]

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6

Timepoint [95]

At Cycle 6 (28 days per Cycle)

Secondary outcome [96]

Number of Intracyclic Bleeding Episodes at Cycle 1

Timepoint [96]

At Cycle 1 (28 days per Cycle)

Secondary outcome [97]

Number of Intracyclic Bleeding Episodes at Cycle 3

Timepoint [97]

At Cycle 3 (28 days per Cycle)

Secondary outcome [98]

Number of Intracyclic Bleeding Episodes at Cycle 6

Timepoint [98]

At Cycle 6 (28 days per Cycle)

Secondary outcome [99]

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Timepoint [99]

At Cycle 1 (28 days per Cycle)

Secondary outcome [100]

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Timepoint [100]

At Cycle 3 (28 days per Cycle)

Secondary outcome [101]

Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

Timepoint [101]

At Cycle 6 (28 days per Cycle)

Secondary outcome [102]

Number of Intracyclic Bleeding Days at Cycle 1

Timepoint [102]

At Cycle 1 (28 days per Cycle)

Secondary outcome [103]

Number of Intracyclic Bleeding Days at Cycle 3

Timepoint [103]

At Cycle 3 (28 days per Cycle)

Secondary outcome [104]

Number of Intracyclic Bleeding Days at Cycle 6

Timepoint [104]

At Cycle 6 (28 days per Cycle)

Secondary outcome [105]

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

Timepoint [105]

At Cycle 1 (28 days per Cycle)

Secondary outcome [106]

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

Timepoint [106]

At Cycle 3 (28 days per Cycle)

Secondary outcome [107]

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6

Timepoint [107]

At Cycle 6 (28 days per Cycle)

Secondary outcome [108]

Percentage of Participants With at Least 1 Intracyclic Bleeding Episode

Timepoint [108]

Up to Cycle 6 (28 days per Cycle)

Eligibility

Key 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

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2009

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/07/2010

Sample size

Target

Accrual to date

Final

217

Recruitment in Australia

Recruitment state(s)

NSW,SA,VIC,WA

Recruitment hospital [1]

Sydney Centre for Reproductive Health Reseach - Ashfield

Recruitment hospital [2]

Royal Hospital for Women - Sydney

Recruitment hospital [3]

Royal Adelaide Hospital - Adelaide

Recruitment hospital [4]

The Alfred Hospital - Prahran

Recruitment hospital [5]

Queen Elizabeth II Medical Centre - Nedlands

Recruitment hospital [6]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

2031 - Ashfield

Recruitment postcode(s) [2]

2031 - Sydney

Recruitment postcode(s) [3]

5000 - Adelaide

Recruitment postcode(s) [4]

3121 - Prahran

Recruitment postcode(s) [5]

6009 - Nedlands

Recruitment postcode(s) [6]

6008 - Subiaco

Recruitment outside Australia

Country [1]

Austria

State/province [1]

Niederösterreich

Country [2]

Austria

State/province [2]

Steiermark

Country [3]

Austria

State/province [3]

Wien

Country [4]

Austria

State/province [4]

Zeltweg

Country [5]

Belgium

State/province [5]

Bruxelles - Brussel

Country [6]

Belgium

State/province [6]

Gent

Country [7]

Belgium

State/province [7]

Leuven

Country [8]

Germany

State/province [8]

Baden-Württemberg

Country [9]

Germany

State/province [9]

Nordrhein-Westfalen

Country [10]

Germany

State/province [10]

Sachsen

Country [11]

Germany

State/province [11]

Hamburg

Country [12]

Italy

State/province [12]

Cagliari

Country [13]

Italy

State/province [13]

Catania

Country [14]

Italy

State/province [14]

Pavia

Country [15]

Italy

State/province [15]

Pisa

Country [16]

Spain

State/province [16]

Barcelona

Country [17]

Spain

State/province [17]

Alicante

Country [18]

Spain

State/province [18]

Granada

Country [19]

Spain

State/province [19]

Madrid

Country [20]

Thailand

State/province [20]

Bangkok

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Bayer

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT00764881

Trial related presentations / publications

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.

Public notes

Contacts

Principal investigator

Name

Bayer Study Director

Address

Bayer

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00764881

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00764881