Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment

This is an interventional treatment trial for Sexual Pain Disorders focused on measuring 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 Read More

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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