Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment (NCT03682601) | Clinical Trial Compass
TerminatedPhase 2
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Stopped: pandemic
United States32 participantsStarted 2018-08-30
Plain-language 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
Who can participate
Age range20 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. For surgically menopausal women, be 20-70 years of age and at least 12 months post menopause.
✓. 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).
✓. Women taking estrogens may enroll in the trial.
✓. 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.
✓. 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.
✓. Be able and willing to participate in the study as evidenced by providing written informed consent.
✓
What they're measuring
1
Numerical Rating Scale for Pain
Timeframe: Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
. Answer affirmatively to all of the following questions:
✓. Before your vulvar pain, would you say that in general, your sex life was good and satisfying?
Exclusion criteria
✕. Have any physical limitations or sexual trauma that would interfere with normal sexual function.
✕. 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 ®).
✕. 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.
✕. Have significant psychiatric disorder, a significant alcohol or drug dependency and/or be receiving pharmacologic treatment for such illness or disorder.
✕. 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.
✕. 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.
✕. Have any infection of the genitalia
✕. Have lichen sclerosis, lichen planus, contact dermatitis, psoriasis or any inflammatory condition or abrasions of the vulva