跳至主要内容
临床试验/ISRCTN12928573
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

发起方
Instituto Palacios de Salud y Medicina de la Mujer

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