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临床试验/CTRI/2019/01/016868
CTRI/2019/01/016868进行中(未招募)未知

A Randomized, Double Blinded, Placebo Controlled Study to evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in women - Femildo study

ADSO Naturals Holdings BV0 个研究点目标入组 24 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
24

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

入选标准

  • 1.Female volunteer with age range 20-50 yrs. actively living with a partner at least 15 days per month, being in child bearing age, lack and or loss of libido which causes distress.
  • 2. BMI of 18-29 kg/m2
  • 3. A face to face interview based on Diagnostic and Statistical Manual Dental Disorders (DSM-IV-TR) codes for HSDD.
  • 4. Willing to give inform consent abiding with trial procedures and come for the follow up visits.

排除标准

  • Pregnant, lactating women and menopause
  • Subjects with any serious illness and undergone any kind of surgery (e.g. tubectomy, hysterectomy etc.) within past 6 months
  • History of genital tract or breast cancers
  • Suffering from major depression disorder or other psychiatric disorders and active plan for divorce.
  • Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc.
  • Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
  • Subjects should not have participated in any other clinical trials during the last 3 months prior to the beginning of this study
  • Inability to take or consume investigational product
  • History of substance misuse.

研究者

发起方
ADSO Naturals Holdings BV

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