The Effect of Non-hormonal Gel Application in Women in the Menacme With Sexual Dysfunction
Condition: Sexual Dysfunction
Study type: Interventional

Summary: 
      The aim of the present randomized, double-blind study is to evaluate the effects of a vulvar,
      moisturizing, non-hormonal gel containing visnadine, ethil ximeninate, Coleus barbatus and
      Panicum miliaceum (TROFIS (R)), in women in the menacme, regarding the sexual response
      measured by the Female Sexual Function Index (FSFI) when compared to placebo.
    

Detailed description: 
      In this study, 60 sexually active (having a male partner, boyfriend or husband) female
      volunteers will be included. All patients will undergo gynecological evaluation of the vulvar
      area and the vaginal mucosa before and after the treatment, by means of visual inspection and
      speculum examination.

      Volunteers will be requested to apply once a day, for four weeks, a small amount of gel to
      the dry area (vulva), followed by a gentle massage to promote the absorption of the product.

      For the time of the study, volunteers will be asked not to change personal hygiene products,
      e.g., moisturizers, soaps, deodorants, etc. Volunteers will be instructed to fill out the
      "diary of use" with the dates of product application and notes about feelings of discomfort
      or subjective reactions, if any. In the final visit, volunteers will answer the FSFI
      questionnaire (see Annex 1). All variables in the questionnaire (comfort during sexual
      intercourse, hydration and softness of genital tissue) will undergo a descriptive analysis.

      In the first moment of the study, patients will receive the FSFI (Female Sexual Function
      Index) questionnaire, self-applied and validated for the Portuguese language in Brazil (Thiel
      et al., 2008). Then, the estronization of external genital organs will be assessed by
      gynecological exam.

      Patients will be randomly assigned to four groups: group A and B (A and B - 30 and 30
      patients in the menacme, following the order defined by the computer-generated randomization
      list.

      During the advertising process, patients will be interviewed by phone following the same
      chronological order of their contacts with the clinic and a medical evaluation will be
      scheduled.

      The participants will be with age greater than 20 old, be in either the menacme (not
      pregnant). They will have complaints about sexual activity, an active sex life, and body mass
      index (BMI) equal to or less than 30. Through these criteria of inclusion and exclusion.

      After collection of clinical history and gynecological anamnesis, these women will undergo a
      general physical examination and gynecological examination, oncotic cytology, and imaging
      examination of the endometrial thickness (transvaginal ultrasonography). With the exams
      results, the women will undergo another medical evaluation.

      All participants will sign the Informed Consent Form (ICF). Patients in the menacme _ Group A
      and B (medicated or placebo) Biolab Farmaceutica (242 Rua das Olimpíadas, 3rd floor, Vila
      Olímpia/São Paulo - SP) will provide free of charge Trofis and placebo (inactive compound)
      gels. All tubes containing the gel will have the same shape and will be labeled with a batch
      number, which carries the information on the content, only known by Biolab. In this manner,
      blindness will be maintained for the entire study time, until the last patient finishes one
      month of treatment. Patients and the physician researcher will not know which gel contains
      the active component or to which group it belongs. The volunteers will apply once a day, for
      four weeks, a small amount of gel to the dry area (vulva), followed by a gentle massage to
      promote the absorption of the product.

      In the end of the first month of treatment, patients will go to the clinic for a follow up to
      ensure treatment adherence and to evaluate potential adverse effects of the gel. After one
      month of treatment, patients will answer the FSFI questionnaire again, and will undergo a
      general clinical examination and gynecological examination of the external genital organs.

      In the end of treatment and with results of complementary exams, patients will be instructed
      to continue attending the gynecological routine consultations in the Ginecologia Endócrina,
      outpatient clinic of EPM/UNIFESP.
    

Intervention name(s): placebo or drug
Intervention type(s): Combination Product
Intervention description(s): Group A and B (medicated or placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind placebo-controlled study with women with age greater than 20, in the menacme, with complaints about sexual activity.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment