ISRCTN12928573进行中(未招募)未知
Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire. Pilot study.
Instituto Palacios de Salud y Medicina de la Mujer0 个研究点目标入组 29 人开始时间: 2019年3月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 29
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31039769 (added 02/05/2019)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •1. Healthy, postmenopausal women (no natural menses for at least 1 year) aged = 45 and = 65. Hysterectomized patients should have an FSH level above 40 IU.
- •2. Stable partner, living together for at least 15 days a month and being sexually available.
- •3. Risk of sexual dysfunction established at FSFI score< 25.83.
- •4. Integrity of the vaginal mucosa (without lesions or bleeding).
- •5. Women willing to and capable of understanding and signing an informed consent after receiving an explanation on the nature of the whole study.
- •6. Consenting to participate in the study and signing the Informed Consent form.
- •7. No desire for pregnancy in the next 3 months.
排除标准
- •1. Pregnant women or with suspected pregnancy.
- •2. Within 3 months following delivery or abortion.
- •3. Breastfeeding women.
- •4. Women with severe pain in sexual relationships (DMS-V).
- •5. Non-diagnosed abnormal genital bleeding or presence of vaginal lesions.
- •6. Women with symptoms of vaginal infection or signs of any other genital infection.
- •7. Women allergic or hypersensitive to the components of the study treatment.
- •8. Severe psychiatric disorder.
- •9. Use of any hormonal treatment with estrogens, progestogens, or estrogens and progestogens within 3 previous months prior to selection.
- •10. Use of any other drug or experimental device within 30 days prior to selection.
- •Any condition preventing the patient from participating in the study, at the researcher’s discretion.
研究者
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