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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
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 Drug: Sinecatechins Topical Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: 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
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: Placebo
Aquaphor/vehicle

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.

Drug: Sinecatechins Topical
Topical sinecatechins ointment will be applied daily.
Other Name: Veregen




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   Yes
Criteria

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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682601


Contacts
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Contact: Lila Nachtigall, M.D. 212-779-8353 doctorlila@gmail.com
Contact: Fred Naftolin, M.D. 212-779-8353 Frederick.Naftolin@nyulangone.org

Locations
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United States, New York
Lila Nachtigall, M.D. Recruiting
New York, New York, United States, 10016
Contact: Lila Nachtigall, M.D.    212-779-8353    doctorlila@gmail.com   
Contact: Annamarie DeRosa    212-779-8353    Clinicaltrialpa@gmail.com   
Sub-Investigator: Dena Harris, M.D.         
Principal Investigator: Lila Nachtigall, M.D.         
Miriam Greene, M.D. Recruiting
New York, New York, United States, 10016
Contact: Miriam Greene, M.D.    212-725-3966    m.greenemd@aol.com   
Contact: Annamarie DeRosa       Clinicaltrialpa@gmail.com   
Principal Investigator: Miriam Greene, M.D.         
Elizabeth Eden, M.D. Recruiting
New York, New York, United States, 10022
Contact: Elizabeth Eden, M.D.    212-355-7103    dr.elizabetheden@gmail.com   
Contact: AnnaMarie DeRosa       Clinicaltrialpa@gmail.com   
Principal Investigator: Elizabeth Eden, M.D.         
Cynthia Krause, M.D. Recruiting
New York, New York, United States, 10128
Contact: Cynthia Krause, M.D.    212-369-0602    info@cynthiakrausemd.com   
Contact: Annamarie DeRosa       Clinicaltrialpa@gmail.com   
Principal Investigator: Cynthia Krause, M.D.         
Janis Enzenbacher, M.D. Recruiting
Nyack, New York, United States, 10960
Contact: Janis Enzenbacher, M.D.    914-325-1664    janiszen@drgyn.us   
Contact: Annamarie DeRosa       Clinicaltrialpa@gmail.com   
Principal Investigator: Janis Enzenbacher, M.D.         
Sponsors and Collaborators
GTO Pharmaceutical, LLC
  Study Documents (Full-Text)

Documents provided by Lila Nachtigall, M.D., Dr. Lila Nachtigall Rapid Medical Research, New York:
Publications:
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Responsible Party: Lila Nachtigall, M.D., Lila Nachtigall, M.D., Professor of Gynecology, Dr. Lila Nachtigall Rapid Medical Research, New York
ClinicalTrials.gov Identifier: NCT03682601    
Other Study ID Numbers: GTO1
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Lila Nachtigall, M.D., Dr. Lila Nachtigall Rapid Medical Research, New York:
Sexual Pain
Postmenopausal Symptoms
Vulvovaginal Atrophy
Vulvodynia
Dyspareunia
Vestibulodynia
Female Sexual Dysfunction
Arousal Disorders, Sexual
Painful Penetration
Painful intercourse
Vular Pain
Pain at vaginal opening
Entrance Pain
Lack of Lubrication
Lack of Arousal
Additional relevant MeSH terms:
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Vulvodynia
Dyspareunia
Vulvar Vestibulitis
Disease
Atrophy
Pelvic Pain
Somatoform Disorders
Sexual Dysfunctions, Psychological
Pathologic Processes
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Signs and Symptoms
Vulvar Diseases
Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male
Mental Disorders
Vulvitis