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

• Conditions: Reduced libido in women with acquired female sexual dysfunction (FSD) associated with oral contraceptive use.; MedDRA version: 9.1Level: LLTClassification code 10030970Term: Oral contraception

• Registration Number: EUCTR2008-002263-13-BE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

1.Signed and dated informed consent
2.Age between 18 and 50 years (inclusive), smokers maximum age of 30 years (inclusive) at Visit 1
3.At screening, the subject must be on the OC which has caused the libido complaints according to their perception. All marketed OCs of the monophasic combined oral contraceptive type (COC), including Microgynon, will be allowed.
4.Must be suffering from reduced libido as a perceived side effect of the OC use (ie, acquired OC-associated FSD) for at least three months, but not longer than one year, and willing to switch to the randomly assigned study treatment (SH T00658ID or Microgynon)
5.Value of 18 or below in the not weighted sum score of FSFI sexual desire and sexual arousal component scores, defined as the total of questions 1 to 6 of the FSFI at Screening and Baseline
6.Sexual relationship with a sexually competent partner
7.Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Female sexual dysfunction such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia
2) Hyperandrogenemic conditions, such as congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), Cushing’s syndrome or signs of hyperandrogenism like severe hirsutism or severe acne
3) Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment)
4) Body mass index (BMI) >32 kg/m2
5) Hypersensitivity to any of the study drug ingredients
6) Vegetarians/ individuals not consuming pork and beef products. Women may be included if they are willing to take the capsules.
7) Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
8) Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results (eg, depression, anxiety, other psychiatric diseases)
9) Any disease or condition that may worsen under hormonal treatment (refer to protocol Section 8.7.2 for details)
10) Undiagnosed abnormal genital bleeding
11) Abuse of alcohol, drugs, or medicines (eg, laxatives)
12) Other contraceptive methods:
• Sterilization
• Oral, vaginal or transdermal hormonal contraception during treatment
• Intra-uterine devices (IUD) with or without hormone release
• IUD still in place within 30 days of Visit 1
• Implants
• Implants/depots still in place within 30 days of Visit 1
• Long acting preparations (eg, Depot-MPA, monthly contraceptive injection) within a period of three times of the injection interval before start of treatment.

13) Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results (refer to protocol Section 8.7.2 for details)
14) Simultaneous participation in another clinical trial. Participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
15) Major surgery scheduled for the study period
16) Recent gynecological surgery which might influence sexual activity
17) Subject is a dependent person, eg; a family member or member of the Investigator’s staff
18) Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified