Eligibility Details:
Inclusion Postmenopausal women
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. In screening their vaginal 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.
4. Be, sexually functional, both psychologically and physically, whereby a woman is to be
psychologically interested in sexual activity and 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 6- week active treatment period of the study and ending at the
8th- week of their participation in the study.
5. Be able and willing to participate in the study as evidenced by providing written
informed consent.
6. 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?
7. Women taking aromatase inhibitors or tamoxifen CAN enter the clinical trial
Exclusion Criteria:
1. Have taken estrogen-containing treatments, either by systemic or local route, for
three months or more.
2. Have any physical limitations or sexual trauma that would interfere with normal sexual
function.
3. Have used estrogen, including vaginal conjugated equine estrogen, or estrogen
progestin therapy, vaginal oestriol or low-dose vaginal oestradiol or any other
exogenous estrogenic compound pharmaceutical including OTC plant based estrogenic
substances in the last 12 weeks. Have used tablet or powder forms of phyto-estrogens
for less than 12 weeks prior to Visit 1 (Week 0).
NOTE: Women taking aromatase inhibitors or tamoxifen CAN enter the clinical trial.
4. 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, PDE5 inhibitors (Viagra ®).
5. Have occasionally used (averaging more than once a week) in the past 30 days the
following preparations that may interfere with the study purpose: DHEA or other drugs
or supplements that may, in the opinion of the Investigator, affect sexual function.
6. 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.
7. Have significant psychiatric disorder, a significant alcohol or drug dependency and/or
be receiving pharmacologic treatment for such illness or disorder.
8. 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.
9. 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 SPVD.
10. Have any infection of the genitalia
11. Have lichen sclerosis, lichen planus, contact dermatitis, psoriasis or any
inflammatory condition or abrasions of the vulva
12. Have an episiotomy scar in the area where pain is perceived as it may confound the
etiology of the perceived pain
13. Have diabetes.
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common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
