Randomized, Double-blind, Two-arms Study With Parallel Groups to Determine the Effect of a Phosphodiesterase Inhibitor for 14 Weeks of Treatment Versus Placebo in Women With FSIAD.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 主要终点
- Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
研究概览
简要总结
This clinical trial is a prospective, randomized, double-blind Phase III study with two arms to determine the efficacy and safety of the use of an IPDE in women with FSIAD.
Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will enter the study and receive active product or placebo for 14 weeks.
Patients will be assigned to each treatment group in a randomized and parallel manner. In addition, all volunteers participating in the study will receive medical advice during the study.
The study will have a duration of minimum of 18 weeks and will consist of 3 periods.
详细描述
This clinical trial is a prospective, randomized, double-blind Phase III study with two arms to determine the efficacy and safety of the use of an IPDE in women with FSIAD.
Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will enter the study and receive active product or placebo for 14 weeks.
Patients will be assigned to each treatment group in a randomized and parallel manner. In addition, all volunteers participating in the study will receive medical advice during the study.
The study will have a duration of minimum of 18 weeks and will consist of 3 periods
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 65 years old. Women of childbearing age (premenopausal, not surgically sterilized at least 3 months before the Selection Visit) must be used during the study a highly effective contraceptive method such as:
- •contraceptive methods or partner vasectomy, and confirm who are not pregnant by pregnancy test negative in the Selection Consultation.
- •Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study.
- •Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria.
- •Exclusion Criteria :
- •The following groups of patients with cardiovascular risk:
- •Patients who had suffered myocardial infarction in the 90s previous days,
- •Patients with unstable angina or angina produced during sexual activity,
- •Patients with heart failure corresponding to class II or higher than the New York Heart Association classification (NYHA) in the previous 6 months,
- •Patients with uncontrolled arrhythmias,
- •Patients who had suffered a stroke in the previous 6 months.
- •Patients with disorders of female sexual arousal of origin neurogenic.
- •Patients with female sexual dysfunction associated with disorders psychiatric.
- •Patients with a partner who suffers from sexual dysfunction.
- •Patients with dysphoric excitation disorder and / or with sensation unpleasant genital thickening.
- •Patients with a history of severe thromboembolic disease, hepatic, renal, or neoplastic.
- •Uncontrolled diabetic patients (HbA1c> 8% in the last control).
- •Patients with depression and / or taking antidepressants.
- •Hypersensitivity to tadalafil and / or drugs and products related (including excipients of the formulation).
- •Patients undergoing treatment with any form of organic nitrate.
- •Patients on treatment with potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, and saquinavir) and strong CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, St. John's wort, rifampin).
- •Patients who have loss of vision in one eye a consequence of anterior ischemic optic neuropathy not arteritic.
- •Patients with any pelvic surgery in the previous 6 months.
- •Known history of drug and / or alcohol abuse in the 6 months prior to the selection consultation.
- •Participation in another study in the 3 months prior to the consultation of selection.
- •Any illness that, in the investigator's judgment, can interfere with compliance with study procedures or study evaluations.
- •Patient with any medical or surgical condition that may interfere with absorption, distribution, metabolism or excretion of the study drug according to the criteria of the researcher.
- •Patients in judicial or police custody.
- •Patients with difficulties in understanding the language in which they gives the information to the subject.
- •Patients who do not agree to the transmission of their anonymous data regarding the documentation and notification functions.
- •Study center, sponsor or CRO staff, their own researcher or relatives of the same.
排除标准
- 未提供
研究组 & 干预措施
Group Active Tadalafile
One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
干预措施: Tadalafil 1,5 mg oral tablets (Drug)
Group Placebo
One oral tablet of placebo daily for 14 weeks of treatment.
干预措施: Placebo oral tablets (Drug)
结局指标
主要结局
Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
时间窗: 14 weeks
To determine the effect of IPDE at a dose of 1.5 mg versus placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index). FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.
次要结局
- Comparative IPDE Vs placebo according to FSFI(14 weeks)
- Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)(14 weeks)
- Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)(14 weeks)
- Comparative of IPDE Vs placebo according to number of sexual events(14 weeks)
- Comparative of IPDE Vs placebo according to the sexual satisfaction(14 weeks)
- Comparative of IPDE Vs placebo according to ease of arousal(14 weeks)
研究者
Lidia Larrañaga
Clinical Trial Coordinator
Laboratorios LITAPHAR, S.L.