NCT00566384已完成2 期
Multi-center, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Daily Oral 100 mg Dehydroepiandrosterone (DHEA) Over 6 Treatment Cycles as a Concomitant Therapy to Oral Contraceptives (OC) to Alleviate Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With OC-use
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 主要终点
- FSDS questionnaire (sexual desire and arousal component scores)
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of the study drug on the libido (sexual desire) of women who are taking oral contraceptives and who have experienced libido reductions as a side-effect of this contraceptive method The hypothesis is that there is superiority in the change in sexual desire and arousal component scores of the FSFI questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Treatment with a oral contraceptive (OC) for at least 3 months and willing to continue the OC
- •Loss of libido
- •Sexual relationship with a sexually competent partner
排除标准
- •Female sexual dysfunction other than HSDD, arousal and orgasmic disorder, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia
- •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
- •Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
- •Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris).
- •History of migraine with focal neurological symptoms.
- •Diabetes mellitus with vascular involvement.
- •Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
- •Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- •Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- •Presence or history of liver tumors (benign or malignant).
- •Known or suspected sex-steroid influenced malignancies (e.g., of the genital organs or the breasts)
- •Undiagnosed vaginal bleeding.
- •Known or suspected pregnancy.
- •Hypersensitivity to the active substances or to any of the excipients.
- •Body-mass index (BMI ) more than 30.0 kg/m²
- •Hypersensitivity to any of the study drug ingredients
- •Any disease or condition 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
- •Known current or history of alcohol or drug abuse
- •Prohibited concomitant medication:
- •Use of additional steroid hormones, anticoagulants (e.g., heparin, coumarin), antiepileptics (hydantoin derivates, e.g., phenytoin or carboxamide derivates, e.g., carbamazepin, oxcarbamazepin), other antiepileptics, (e.g., Felbamate, Topiramate), hypnotic and sedative (e.g., barbiturate derivates, primidone), tuberculostatics (e.g., rifampicin), oral antimycotics (e.g., griseofulvin, ketoconazole, itraconazole, fluconazol), virostatic agents (e.g., ritonavir), and products containing St. John's wort and continuous systemic use of antibiotics.
- •Medication with influence on libido (e.g., antihypertensives like beta-adrenergic blocker, cholinesterase blocking agents), psychotropic drugs (e.g., antidepressants, neuroleptic agents, selective serotonin reuptake inhibitors [SSRIs]), lipid lowering drugs and H2 blockers.
- •Intake of an experimental drug within 3 months prior to inclusion in the study
- •Previous assignment to treatment (e.g., randomization) during this study
- •Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site).
- •Operation scheduled in the study period
- •Abnormal laboratory values within the non-inclusion range
- •Patient is in custody by order of an authority or a court of law
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Dehydroepiandrosterone, BAY86-5314 (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
FSDS questionnaire (sexual desire and arousal component scores)
时间窗: at baseline and after Cycle 6
次要结局
- Serum hormone levels (SHBG, T, DHEA, DHEA-S)(Cycle 1, 3, 6 and follow-up)
- PGWBI questionnaire results(Cycle 1, 3, 6 and follow-up)
- FSDS-R questionnaire results(Cycle 1, 3, 6 and follow-up)
- Change from baseline period to cycle 6 in the number of satisfactory sexual events(after Cycle 6)
- FSFI questionnaire (absolute values and change from baseline) - All domains(Cycle 1, 3, 6 and follow-up)
- FSEP questionnaire results(Cycle 1, 3, 6 and follow-up)
- Vaginal pH(Cycle 1, 3, 6 and follow-up)
研究者
相似试验
已完成
3 期
Effects of Antidepressants on Sexual FunctioningMajor Depressive Disorder (MDD)NCT00051259GlaxoSmithKline420
撤回
不适用
Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire LevelsFemale Sexual Interest/Arousal DisorderNCT04188600Procare Health Iberia S.L.
Unknown
2 期
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial VaginosisHUDC_VTHaudongchunBacterial VaginosisNCT03357666Haudongchun Co., Ltd.150
已完成
2 期
Phase II Study of STA-2 in Patients With Chronic Stable AnginaChronic Stable AnginaNCT01484912Sinphar Pharmaceutical Co., Ltd79
已完成
3 期
Clinical Study Of Schizophrenia in Both Men and WomenSchizophreniaNCT00071747GlaxoSmithKline176