EUCTR2006-001179-39-DE进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-group, Multicentre, 24 week Study to Evaluate the Efficacy and Safety of Transdermal Testosterone (300 mcg/day) in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen, Oral Non-Conjugated Equine Estrogen, or No Estrogen Therapy - ADORE
Procter & Gamble Pharmaceuticals0 个研究点目标入组 270 人开始时间: 2006年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Women will be screened for study participation according to the following inclusion criteria at Week –4. Eligible women must:
- •a) be 40 to 70 years old and in general good health based on medical history, physical examination, and laboratory evaluation;
- •b) have no spontaneous menstrual periods for 1 year (if post-hysterectomy, the woman must have at least 1 ovary. For hysterectomised women < 50 years of age, a screening follicle stimulating hormone [FSH] level > 30 IU/L is required to confirm
- •menopausal status (a previously documented FSH level in the clinical notes of
- •> 30 IU/L confirming the menopausal transition will also be acceptable);
- •c) be receiving a stable dose of an approved systemic transdermal estrogen or oral non-CEE (estrogen implants are not acceptable), if hysterectomised, or an approved
- •continuous systemic transdermal estrogen or oral non-CEE plus transdermal or oral
- •progestogen, if not hysterectomised, for at least 12 weeks prior to screening with the intention of maintaining that regimen throughout the study or not currently receiving any hormone replacement therapy (having stopped hormone replacement therapy at least 12 weeks before screening) with the intention of not starting hormone replacement therapy during the study;
- •d) have a clinically acceptable screening bilateral mammogram (no evidence of malignancy) as determined by a local radiologist. A clinically acceptable mammogram is one in which the report requests a follow-up in the standard timeframe. A documented result of a previous mammogram done up to 1 year prior to screening is acceptable; for clinical sites in Germany, a screening bilateral mammogram by a local radiologist will not be performed; only documented results from a previous mammogram done up to 1 year prior to screening will be used to assess eligibility;
- •e) have a clinically acceptable Pap smear (no evidence of malignancy or squamous intraepithelial lesions) if the cervix is present. A Pap smear at study entry may be performed on patients without a cervix at the discretion of the investigator;
- •f) be, in their own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least 1 year prior to study entry. The relationship must be with the same partner who is sexually functional, both psychologically and physically; and is expected to be physically present (i.e., available for sexual activity at some time during a 24-hour day) at least 50% of each month during the 4-week pretreatment and 24-week efficacy treatment period of the study;
- •g) be able and willing to participate in the study as evidenced by providing written informed consent;
- •h) answer affirmatively to ALL of the following questions:
- •1. Before your menopause, would you say that in general, your sex life was good and satisfying?
- •2. Since your menopause, do you feel you have experienced a meaningful loss in your level of desire for sex?
- •3. Since your menopause, do you feel you have experienced a significant decrease in your sexual activity?
- •4. Are you concerned about or bothered by your current level of desire for or interest in sex?
- •5. Would you like to see an increase in your level of interest in or desire for sex and sexual activity?
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women will be screened for study participation according to the following exclusion criteria at Week –4 or as specified. Eligible women must not:
- •a) have dyspareunia not alleviated by lubricants, any physical limitations, or sexual trauma that would interfere with normal sexual function;
- •b) have received marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy at any time during the past 3 months, or investigational implantable androgen therapy at any time during the past 7 months;
- •c) have received anti-androgen therapy or topical minoxidil for androgenic alopecia within the last 5 years;
- •d) have used within the last 12 weeks any of the following medications/preparations that may affect sexual function or otherwise interfere with interpretation of the study results: systemic corticosteroids (acute use for less than 7 days is accepted), non-selective and selective serotonin reuptake inhibitors, tricyclic anti-depressants, systemic beta-blockers , anti-adrenergics, spironolactone, apomorphine, PDE5 inhibitors (e.g., Viagra), tibolone, or selective estrogen receptor modulators, including tamoxifen;
- •e) have occasionally used (averaging more than once a week) in the past 30 days the following preparations that may interfere with interpretation of the study results: dehydroepiandrosterone (DHEA) or other drugs or supplements that may, in the opinion of the Investigator, affect sexual function;
- •f) have used tablet or powder forms of phytoestrogens for less than 12 weeks prior to Week –4. Stable use of phytoestrogens for 12 weeks or longer is acceptable, but should be maintained during the study period;
- •g) be experiencing any chronic or acute life stress relating to any major life change, such as recent loss of income or the death of a close family member, that may, in the opinion of the Investigator, significantly interfere with sexual activity;
- •h) have significant psychiatric disorder (including mild depressive disorder), a significant alcohol or drug dependency and/or be receiving pharmacologic treatment for such illness or disorder. For countries using the Beck Depression Inventory II (BDI-II), patients will be excluded if they have a score equal or larger than 14. For Germany, patients will be excluded if they have a score equal or larger than 10 on the BDI-I;
- •i) have current severe dermatological problems (e.g., severe or cystic acne), including concomitant skin disease or history of drug-induced contact dermatitis;
- •j) have a known or suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal systems;
- •k) have participated in a cumulative irritation test within the past 12 weeks;
- •l) have participated in a clinical trial or received an investigational medication within 30 days (exception: women participating in non-treatment observational studies may be included);
- •m) have evidence of clinically significant organic disease on the history and/or physical examination that would, in the opinion of the Investigator, put the patient at risk, prevent the patient from completing the study, or otherwise affect the outcome of the study;
- •n) have a history of breast cancer or estrogen-dependent neoplasia (e.g., endometrial cancer) or any gynecological cancer at any time before study entry or other cancer (except basal or squamous cell carcinoma) within the last 5 years;
- •o) have had gynecological or breast surgery within the last 6 months;
- •p) have acute
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