Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological
Intervention: Ospemifene; Vaginal conjugated estrogens
Intervention description: Ospemifene is a selective estrogen receptor modulator (SERM), and it is the only SERM approved in the United States to treat moderate to severe dyspareunia associated with VVA. It is an oral medication that is taken as a 60mg tablet once daily. Food intake increases its absorption by 2 to 3-fold, and this is not impacted by the fat or calorie content of the food. It is metabolized primarily in the liver, and is excreted in feces.; Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Vaginal estrogen is considered the medication of choice for treating vulvovaginal atrophy (VVA).
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Female sexual disorder; Aging; Menopause; Obstetrics/Gynecology; Female urogenital disorder

Summary:

      Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing
      postmenopausal female population, and the most common symptom is dyspareunia. Vaginal
      estrogen is the most common treatment for VVA, but it only marginally improves overall sexual
      function, and many women and clinicians avoid using it because of the risks of exogenous
      estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor
      modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown
      superb improvements in overall sexual health. 104 women will be randomized to receive 12
      weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated
      estrogens, which is placed vaginally twice per week. The improvements in sexual health and
      VVA symptom severity will be compared in each group. This study will help determine if
      ospemifene is a better treatment medication than conjugated estrogens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Interested in resuming or continuing sexual activity

          -  Greater than 12 months since last menstrual cycle or prior bilateral oophorectomy

          -  Dyspareunia as a vulvovaginal atrophy symptom

          -  Normal mammogram within 12 months prior to entry into the study

        Exclusion Criteria:

          -  History or suspicion of breast carcinoma

          -  History of hormone-dependent tumor

          -  Genital bleeding of unknown cause

          -  Ongoing vaginal infection

          -  History of cerebrovascular accident (CVA), myocardial infarction (MI) or heart disease

          -  Uncontrolled hypertension (HTN) over 160/100

          -  Serious disease or chronic condition that may prevent completion of study

          -  Body Mass Index (BMI) over 40

          -  Hypercoagulable state, or currently on anticoagulant therapy

          -  Use of any exogenous sex hormone within three months from study entry, or during the
             study

          -  Pelvic surgery within the last 12 months