ISRCTN10669888进行中（未招募）Unknown
Investigating the effects of kisspeptin in postmenopausal women with hypoactive sexual desire disorder
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women =40 years old
- •2. Postmenopausal (i.e., no spontaneous period for > 1 year) caused by natural menopause
- •3. Heterosexual
- •4. Right-hand dominant
- •5. Body mass index (BMI) 18-30 kg/m2
- •6. Currently in a relationship and the relationship has been stable for at least 6 months before screening
- •7. The participant’s partner must be sexually functional without erectile dysfunction or premature ejaculation
- •8. In the subject’s opinion, previously experienced normal sexual function,” defined as a normal level of desire at some point in the past
- •9. Hypoactive Sexual Desire Disorder according to the International Classification of Diseases 11th Revision (ICD-11), including categorisation as both acquired (versus lifelong) and generalised (versus situational)
- •10. All of the following at Screening:
- •10.1. Patient Health Questionnaire (PHQ-9) total score is <5, and score for Question 9 is 0
- •10.2. Generalised Anxiety Disorder (GAD-7) total score is <5
- •10.3. Either Female Sexual Function Index (FSFI) total score =26 if diagnosed with HSDD (with or without symptoms of decreased arousal) or subjects diagnosed with HSDD only (without symptoms of decreased arousal), FSFI desire domain score of =5 (regardless of total FSFI score)
- •10.4. Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO) total score is >18
- •11. Receiving systemic Hormone Replacement Therapy (HRT) and be on a stable dose for at least 6-months prior to screening with the intention of maintaining that regimen during the study
- •12. Prior experience in viewing sexually explicit material
- •13. Participants must be able to provide full informed consent. We will make every reasonable effort to accommodate a participant who does not speak English as their first language, such as using an interpreter. However, where there is doubt as to whether the potential participant can fully understand the study, we will not be able to include them as their consent would not be fully informed and there may be difficulty in performing the tasks required for the study which would impact the data collected and hence the robustness of the study
排除标准
- •1. History of any medical, psychological, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the participant.
- •2. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent.
- •3. History of major haematological, renal, thyroid, or hepatic abnormalities or significant cardiovascular disease.
- •4. History of significant pelvic surgery (including hysterectomy).
- •5. History of cancer.
- •6. History of unresolved sexual trauma/abuse
- •7. Diagnosis of another sexual disorder.
- •8. Receiving any other treatment for HSDD (beyond HRT) at the time of screening, such as testosterone therapy.
- •9. Any implanted material in the body that would preclude magnetic resonance imaging (MRI) for safety reasons.
- •10. Inability to tolerate MRI scanning (e.g., claustrophobia or inability to lie flat).
- •11. Impaired vision which would preclude the ability to view erotic material.
- •12. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study.
- •13. History of hypersensitivity to any of the components administered.
- •14. Participation in any research study within the preceding 30 days (or 2 months if an investigational drug was administered).
- •15. Those who have or intend to donate blood or blood products within three months before or following study completion.
研究者
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