Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Condition: Sexual Pain Disorders; Postmenopausal Symptoms; Vulvovaginal Atrophy; Female Sexual Dysfunction; Dyspareunia; Vulvodynia; Vestibulodynia; Arousal Disorders, Sexual; Genito-Pelvic Pain/Penetration Disorder; Female Sexual Arousal Disorder
MeSH terms: Dyspareunia; Vulvodynia; Vulvar Vestibulitis; Atrophy; Pelvic Pain; Somatoform Disorders; Sexual Dysfunctions, Psychological
Intervention: 5% sinecatechins ointment; Placebo; 10% sinecatechins ointment
Intervention description: Topical 5% sinecatechins ointment will be applied once daily.; Aquaphor/vehicle; Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double Blinded, Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blinded
Enrollment: 32.0
Sex: Female
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sexual Pain; Postmenopausal Symptoms; Vulvovaginal Atrophy; Vulvodynia; Dyspareunia; Vestibulodynia; Female Sexual Dysfunction; Arousal Disorders, Sexual; Painful Penetration; Painful intercourse; Vulvar Pain; Pain at vaginal opening; Entrance Pain; Lack of Lubrication; Lack of Arousal

Summary:

      This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived
      from green tea for the alleviation of sexual pain in the area around the vaginal opening (the
      vulvar vestibule), that is a main source of pain during sexual contact or dyspareunia, in
      postmenopausal women, with vulvovaginal atrophy. Women may or may not be using estrogens.
      Half of the women will receive the study drug, 5 or 10% sinecatechins and half will receive
      placebo. In addition to the reduction or elimination of pain upon penetration, women may also
      experience increase in lubrication, arousal and intensity of orgasm
    

Eligibility criteria:

        Inclusion Criteria:

        Generally healthy women must meet the following eligibility criteria:

          1. For surgically menopausal women, be 20-70 years of age and at least 12 months post
             menopause.

          2. For naturally postmenopausal women, be 40-70 years of age and at least 1 year post
             menopause (defined as no spontaneous menses for 1 year).

          3. Women taking estrogens may enroll in the trial.

          4. For women who are not taking any estrogen or who are taking an aromatase inhibitor, In
             screening their vaginal power of hydrogen (pH) will be 4.6 or greater and their
             vaginal maturation index will be consistent with vaginal atrophy. Vaginal atrophy is
             thinning, drying and of the vaginal walls due to having less estrogen in the body.

          5. Be, sexually functional, both psychologically and physically, whereby a woman is to be
             psychologically interested in sexual activity and (unless these activities are
             precluded by pain) is physically sexually active with regular vestibular including
             vaginal introital genital manipulation whether through masturbation or partner sex,
             whether using digits, oral sexual contact, sex toys, and/or penile penetration present
             at regular intervals each month during the 4-week pre-treatment and the 4- week active
             treatment period of the study and ending at the 6th- week of their participation in
             the study.

          6. Be able and willing to participate in the study as evidenced by providing written
             informed consent.

          7. Answer affirmatively to all of the following questions:

               1. Before your vulvar pain, would you say that in general, your sex life was good
                  and satisfying?

               2. Since you have been experiencing vulvar pain, do you feel you have experienced a
                  meaningful loss in your desire for sex?

               3. Since experiencing vulvar pain, do you feel you have experienced a significant
                  decrease in your sexual activity?

               4. Are you concerned or bothered by your current level of desire for or interest in
                  sex?

               5. Would you like to see an increase in your level of interest or desire for sex and
                  sexual activity?

          8. Women can enter the trial if they are taking estrogens.

          9. Women can enter the trial if they are taking DHEA.

         10. Women can enter the trial if they are not taking estrogens.

         11. Women can enter the trial if they are taking aromatase inhibitors.

        Exclusion Criteria:

          1. Have any physical limitations or sexual trauma that would interfere with normal sexual
             function.

          2. Have used within the last 12 weeks any of the following medications/preparations that
             may interfere with the study purpose: systemic corticosteroids (acute use for fewer
             than 7 days is accepted), SSRI's, tricyclic antidepressants, anti-androgens,
             spironolactone, phosphodiesterase type 5 (PDE5) inhibitors (Viagra ®).

          3. Be experiencing any chronic or acute life stress relating to any major life change,
             such as recent loss of income or the death of a close family member, that may, in the
             opinion of the Investigator, significantly interfere with sexual function.

          4. Have significant psychiatric disorder, a significant alcohol or drug dependency and/or
             be receiving pharmacologic treatment for such illness or disorder.

          5. Have evidence of clinically significant organic disorder on the history and/or
             physical examination that would, in the opinion of the Investigator, put the patient
             at risk, present the patient from completing the study, or otherwise affect the
             outcome of the study.

          6. Have a history of genital herpes because of the episodic nature of genital herpes and
             of the known possibility of occurrence of herpetic pain without visible dermatologic
             manifestations of herpes. Genital herpes and its accompanying genital pain may obscure
             the source of the genital pain experienced and confound the ability to determine the
             efficacy of treatment/placebo on endpoint of alleviation of pain in women with
             secondary provoked vulvar vestibular pain.

          7. Have any infection of the genitalia

          8. Have lichen sclerosis, lichen planus, contact dermatitis, psoriasis or any
             inflammatory condition or abrasions of the vulva

          9. Have an episiotomy scar in the area where pain is perceived as it may confound the
             etiology of the perceived pain

         10. Have diabetes.

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