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Trial record 2 of 3 for:    green tea | Recruiting, Not yet recruiting Studies | New York, United States

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

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ClinicalTrials.gov Identifier: NCT03682601
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Lila Nachtigall, M.D., Dr. Lila Nachtigall Rapid Medical Research, New York

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE September 24, 2018
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE August 30, 2018
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2020)
Numerical Rating Scale for pain [ Time Frame: Change in the Numerical Rating Scale for pain will be assessed weekly for 6 weeks. ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
Numerical Rating Scale for pain [ Time Frame: Change in the Numerical Rating Scale for pain will be assessed weekly for 6 weeks and then finally at the end of week 12 ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2020)
  • Female Sexual Function Index Questionnaire; [ Time Frame: to be answered at the initial office visit, then at the end of 2 weeks, then at the end of 4 weeks, and then at the end of 6 weeks ]
    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.
  • Female Sexual Distress Questionnaire revised [ Time Frame: to be answered at the initial office visit, then at the end of 2 weeks, then at the end of 4 weeks, and then at the end of 6 weeks ]
    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.
  • Vulvovaginal Symptoms Questionnaire [ Time Frame: to be answered at the initial office visit, then at the end of 2 weeks, then at the end of 4 weeks, and then at the end of 6 weeks ]
    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
  • Sexual Activities Log [ Time Frame: To be answered at the initial office visit then at the end of each week for 6 weeks. ]
    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.
  • Vaginal pH [ Time Frame: To be performed at each office visit , the first office visit; and at the end of the 4th week office visit ]
    A vaginal speculum exam will be performed by the gynecologist to evaluate with a pH paper the vaginal pH
  • Vaginal maturation index [ Time Frame: To be performed twice, once at the first office visit and then at the end of the 4th week office visit ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • Female Sexual Function Index Questionnaire [ Time Frame: to be answered at the initial office visit, then at the end of 3 weeks, then at the end of 6 weeks, and then at the end of 12 weeks ]
    19 multiple choice questions about sexual function
  • Female Sexual Distress Questionnaire revised [ Time Frame: to be answered at the initial office visit, then at the end of 3 weeks, then at the end of 6 weeks, and then at the end of 12 weeks ]
    Yes or No questions to evaluate level of distress from vestibulodynia
  • Vulvovaginal Symptoms Questionnaire [ Time Frame: to be answered at the initial office visit, then at the end of 3 weeks, then at the end of 6 weeks, and then at the end of 12 weeks ]
    Yes or No questions to evaluate characteristics of symptoms subject is experiencing
  • Sexual Activities Log [ Time Frame: To be answered at the initial office visit then at the end of each week for 6 weeks and then at the end of week 12 ]
    Questionnaire to determine frequency of satisfying sexual activity during the past week that the subject has experienced
  • Vaginal pH [ Time Frame: To be performed at each office visit , the first office visit; at the end of the 3rd week office visit, at the end of the 6th week office visit ]
    A vaginal speculum exam will be performed by the gynecologist to evaluate with a pH paper the vaginal pH
  • Vaginal maturation index [ Time Frame: To be performed twice, once at the first office visit and then at the end of the 6th week office visit ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Official Title  ICMJE 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
Brief Summary This study will evaluate the use of topical 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, 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
Detailed Description

Topical Veregen (15% sinecatechins) is an FDA approved botanical drug derived from green tea and is approved to be used as multiple doses, three times a day to treat all visible external genital warts.

Topical green tea ointment has been shown to alleviate pain and improve wound healing in the vulvar vestibule for women who have had a recent episiotomy in the medical literature. In private clinical practice, dilute Veregen (10% sinecatechins) has been effective in alleviating , sexual pain, vulvar vestibular pain, dyspareunia, in postmenopausal women as well as improving overall sexual satisfaction,( increasing lubrication, arousal and quality of orgasm). In this study, dilute Veregen, (10% sinecatechins) or placebo is being applied, as a single dose, topically, once a day, to alleviate pain in the vulvar vestibule, penetration pain, upon sexual contact or other manipulation of this area in postmenopausal women. Women are eligible whether or not they are currently using any form of estrogen or other hormonal treatments (eg.DHEA). Please note that women not using estrogen or who maybe taking aromatase inhibitors,tamoxifen, SERMS, are also eligible to be included.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: Sinecatechins Topical
    Topical sinecatechins ointment will be applied daily.
    Other Name: Veregen
  • Other: Placebo
    Aquaphor/vehicle
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    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.

    Intervention: Other: Placebo
  • Active Comparator: 10% Topical sinecatechins ointment

    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.

    Intervention: Drug: Sinecatechins Topical
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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 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, 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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: 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.
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lila Nachtigall, M.D. 212-779-8353 doctorlila@gmail.com
Contact: Fred Naftolin, M.D. 212-779-8353 Frederick.Naftolin@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03682601
Other Study ID Numbers  ICMJE GTO1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lila Nachtigall, M.D., Dr. Lila Nachtigall Rapid Medical Research, New York
Study Sponsor  ICMJE GTO Pharmaceutical, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GTO Pharmaceutical, LLC
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP