ISRCTN03247616已完成2 期
A double-blind, placebo controlled, randomised, comparative 2-way crossover study to determine the effect of concomitant treatment with an androgen on sexual arousability and the vascular component of the sexual arousal response during self-induced erotic fantasy and visual stimulation in women using oral contraception
Pantarhei Bioscience BV (Netherlands)0 个研究点目标入组 81 人开始时间: 2009年12月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29490289 (added 14/10/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy females between 20 and 35 years of age
- •2. Using OC for at least three consecutive cycles prior to screening
- •3. Stable, heterosexual relationship for at least 3 months prior to screening
- •4. Willing to interrupt OC use for a period of 4 weeks
- •5. Regular menstrual cycle (24 - 35 days) prior to last start of OC use
- •6. Body mass index (BMI) between (greater than or equal to) 18 and (less than or equal to) 35 kg/m^2
- •7. Good physical and mental health
- •8. Sign a written informed consent agreement
排除标准
- •1. Maudsley Marital Questionnaire (MMQ) General Marital Satisfaction Scale Score greater than or equal to 20; Symptoms Checklist-90 (SCL-90) Depression Scale score greater than or equal to 28; SCL-90 Anxiety Scale Score greater than or equal to 18
- •2. Hormonal contraception use during the 1 cycle prior to the start study medication
- •3. Use of non-oral hormonal contraception in the 3 months prior to the screening
- •4. Total T value greater than 5 nmol/L at time of screening or at the pre-test vaginal photoplethysmograph (VPP) session
- •5. Androgen therapy during the 6 months prior to screening
- •6. Intention to become pregnant during the study
- •7. Lactation and/or pregnancy in the previous 6 months prior to screening
- •8. Any clinically significant abnormality following review of medical history, laboratory results and physical examination at screening
- •9. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening
- •10. Use of one or more of the following medications: psychoactive drugs, anti-hypertensive drugs, sex steroids other than the current OC
- •11. Present use or use within 30 days before the start of the study medication of the following drugs: hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St John's wort (Hypericum perforatum)
- •12. Administration of any other investigational drug within 3 months prior to screening
研究者
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