Effects of SH T00658ID on Libido

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception; Libido

Treatments: Drug: Placebo; Drug: Microgynon; Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764881

310785 (Other Identifier)

2008-002263-13 (EudraCT Number)

91548

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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217 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

EE/LNG (Microgynon) + Placebo

Active Comparator group

Description:

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:

Drug: Microgynon

Drug: Placebo