Sexual Pain DisordersPhase 2NCT03682601
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
A Phase 2 study testing 5% sinecatechins ointment and 10% sinecatechins ointment in people with Sexual Pain Disorders and Postmenopausal Symptoms, run by GTO Pharmaceutical, LLC at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy
- What is being tested?
- 5% sinecatechins ointment and 10% sinecatechins ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Aug 2018to 13 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy women must meet the following eligibility 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.
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- Be able and willing to participate in the study as evidenced by providing written informed consent.
- 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?
- Since you have been experiencing vulvar pain, do you feel you have experienced a meaningful loss in your desire for sex?
- Since experiencing vulvar pain, do you feel you have experienced a significant decrease in your sexual activity?
- Are you concerned or bothered by your current level of desire for or interest in sex?
- Would you like to see an increase in your level of interest or desire for sex and sexual activity?
- Women can enter the trial if they are taking estrogens.
- Women can enter the trial if they are taking DHEA.
- Women can enter the trial if they are not taking estrogens.
- Women can enter the trial if they are taking aromatase inhibitors.
Who cannot join
- 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.
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- Have any infection of the genitalia
- Have lichen sclerosis, lichen planus, contact dermatitis, psoriasis or any inflammatory condition or abrasions of the vulva
- Have an episiotomy scar in the area where pain is perceived as it may confound the etiology of the perceived pain
- Have diabetes.
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lila Nachtigall, M.D.
New York, New York, 10016
Miriam Greene, M.D.
New York, New York, 10016
Cynthia Krause, M.D.
New York, New York, 10128
Janis Enzenbacher, M.D.
Nyack, New York, 10960
About this study
Official title: 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
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
Read the 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, sinecatechins ointment, 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, (5 or 10% sinecatechins) or placebo is being applied, as a single dose, topically, three times/week up to 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.
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction, Dyspareunia, Vulvodynia
- Being tested
- 5% sinecatechins ointment, Placebo, 10% sinecatechins ointment
- Keywords
- Sexual Pain, Postmenopausal Symptoms, Vulvovaginal Atrophy, Vulvodynia, Dyspareunia, Vestibulodynia, Female Sexual Dysfunction, Arousal Disorders, Sexual, Painful Penetration, Painful intercourse, Vulvar Pain, Pain at vaginal opening, Entrance Pain, Lack of Lubrication, Lack of Arousal
- Medical subject headings
- Dyspareunia, Vulvodynia, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% sinecatechins ointmentDrug
Also called Veregen ointment
Topical 5% sinecatechins ointment will be applied once daily.
PlaceboDrug
Also called Aquaphor
Aquaphor/vehicle
10% sinecatechins ointmentDrug
Also called Veregen ointment
Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 15 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. Receives: Drug: Placebo |
| 5% Topical sinecatechins ointment | Active comparator | 15 postmenopausal women will apply a 1/2 inch strand of 5% 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. Receives: Drug: 5% sinecatechins ointment |
| 10% Topical sinecatechins ointment | Active comparator | 15 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. Receives: Drug: 10% sinecatechins ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale for Pain
Scale Title: Numerical Pain Scale to measure overall pain perceived from vulvar vestibule.
Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule.
The mean (standard error) for Numerical Pain Scale at each visit was calculated. A higher Numerical Rating Score means worse outcome and lower Numerical Rating Score means a better outcome. The following Numerical Rating Scale categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
Measured: Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
Secondary outcomes (1)
Q-tip Test Test for Pain on the Vulvar Vestibule
Scale Title: Q-tip test of vulvar vestibular pain. Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule.
The mean (standard error) for Q-tip test at each visit was calculated. A higher Q-tip score means worse outcome and lower Numerical Rating Score means a better outcome. The following Q-tip test categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
Measured: Q-tip test score for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start30 Aug 2018
- Primary completion12 Feb 2021
- Study completion13 Feb 2021
Why it stopped: pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual Pain DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double Blinded, Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTO Pharmaceutical, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lila Nachtigall, M.D., Dr. Lila Nachtigall Rapid Medical Research, New York
- Investigators
- Lila Nachtigall, M.D., Principal investigator, Rapid Medical Research, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682601
- Sponsor's protocol ID
- GTO1
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2018
- Last updated
- 27 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
PubMed 29235159Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283.
PubMed 24807329
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03682601
- Acronym / sponsor ID
- GTO1
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction, Dyspareunia, Vulvodynia
- Keywords
- Sexual Pain, Postmenopausal Symptoms, Vulvovaginal Atrophy, Vulvodynia, Dyspareunia, Vestibulodynia, Female Sexual Dysfunction, Arousal Disorders, Sexual
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: pandemic
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GTO Pharmaceutical, LLCUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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, sinecatechins ointment, 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, (5 or 10% sinecatechins) or placebo is being applied, as a single dose, topically, three times/week up to 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double Blinded, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo15 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. |
| 5% Topical sinecatechins ointment | Active comparator | Drug: 5% sinecatechins ointment15 postmenopausal women will apply a 1/2 inch strand of 5% 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. |
| 10% Topical sinecatechins ointment | Active comparator | Drug: 10% sinecatechins ointment15 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 questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% sinecatechins ointmentAlso: Veregen ointmentTopical 5% sinecatechins ointment will be applied once daily. | Drug | 5% Topical sinecatechins ointment |
| PlaceboAlso: AquaphorAquaphor/vehicle | Drug | Placebo |
| 10% sinecatechins ointmentAlso: Veregen ointmentTopical 10% sinecatechins ointment will be applied three times per week up to once daily. | Drug | 10% Topical sinecatechins ointment |
Primary outcome
Numerical Rating Scale for Pain
Time frame: Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
Scale Title: Numerical Pain Scale to measure overall pain perceived from vulvar vestibule. Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule. The mean (standard error) for Numerical Pain Scale at each visit was calculated. A higher Numerical Rating Score means worse outcome and lower Numerical Rating Score means a better outcome. The following Numerical Rating Scale categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
1 secondary outcome
Q-tip Test Test for Pain on the Vulvar Vestibule
Time frame: Q-tip test score for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29235159Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
- Background: PubMed 24807329Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lila Nachtigall, M.D. principal investigator
Rapid Medical Research, New York
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% sinecatechins ointment and 10% sinecatechins ointment in people with Sexual Pain Disorders and Postmenopausal Symptoms, run by GTO Pharmaceutical, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale for Pain (time frame: Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.