30 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaires during office visits with the gynecologist. In addition, 2 short questionnaires will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3.

30 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaires during office visits with the gynecologist. In addition, 2 short questionnaires will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3.

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

Participant must be a postmenopausal female who has not menstruated for at least one year either because of surgical removal of ovaries and uterus or because of natural menopause. Women taking estrogens, DHEA, can continue to use them during the clinical trial. Women not taking estrogens or are on aromatase inhibitors can enter the trial.

Topical sinecatechins ointment will be applied daily.

Sinecatechins Topical

Placebo

Lila Nachtigall, M.D.

Miriam Greene, M.D.

Elizabeth Eden, M.D.

Cynthia Krause, M.D.

Janis Enzenbacher, M.D.

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

10% Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy

Subjects will be asked to rate their pain 0=no pain, 1-3= mild pain, 4-6 =moderate pain; 7-9= significant pain and 10= severe pain

19 questions (6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain). 2 questions for Desire score range 1-5, The sum is multiplied by 0.6 with subscale score range 1.2 to 6.0; 4 questions for Arousal with score range 0-5. The sum is multiplied by 0.3 with a subscale score range 0-6; 4 questions for Lubrication with score range from 0-5. The sum is multiplied by 0.3 with a subscale score range 0-6; 3 questions in the Orgasm with score range from 0-5. The sum is multiplied by 0.4 with a subscale score range from 0-6 ; 4 questions in Satisfaction, 2 questions with a score range 0-5 and 2 questions with a score range 1-5. The sum is multiplied by 0.4 with a subscale score range 0-6; 3 questions in the Pain with score range 0-5. The sum is multiplied by 0.4 with a subscale score 0-6. The Total score 1.2-36.0 equals sum of subscale scores. Lower values are a worse outcome. A Total score of < or= to 26.55 equals Female Sexual Dysfunction.

There are 13 questions to evaluate the level of sexual distress being. For each question the scale range is from 0 - 4. The total score is the derived from the sum of the individual scores from each of the 19 questions. A score of 11 or higher indicates sexual distress.

There are Yes or No questions to evaluate characteristics of symptoms subject is experiencing. The scale range for each question is 0-1. No is scored as 0 and Yes is scored as 1. Higher scores indicate that the subject is experiencing more vulvovaginal symptoms

Questionnaire to determine, level of sexual desire, distress about level of sexual desire, whether a subject engaged in sexual activity, frequency of sexual activity, satisfaction with sexual activity, and whether a subject had an orgasm during sexual activity during the past week. Question 1 has a scale range from 0-3. For question 1 a higher value indicates more sexual desire. Question 2 has a scale range from 0-4. For question 2 a higher value indicates more distress over level of sexual desire. Question 3 has scale range of 0-1 and is a yes or no question about masturbation; Question 4 asks the number of times that the subject had sex during the past week and has a minimum score of 0 and no maximum score. Questions 5 and 6 are Yes or No questions with a 0-1 scale range. Question 5 asks about was sex satisfying. Question 6 asks about whether the subject has an orgasm. The scores to the questions are not combined but reported individually.

A vaginal speculum exam will be performed by the gynecologist to evaluate with a pH paper the vaginal pH

A vaginal speculum exam will be performed by the gynecologist and a gentle swabbing of the lateral vaginal wall will be performed to assess the degree of vaginal atrophy in the postmenopausal subject

atrophic vaginitis/caiméilia

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

An bunachar luibheanna míochaine is iomláine le tacaíocht ón eolaíocht