GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Breast Cancer Female Clinical Trial

— GSM  

Official title:

GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03185169
• Other study ID #: GSM
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 18, 2016
• Est. completion date: July 23, 2018

Study information

• Verified date: July 2018
• Source: Alta Bates Summit Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.

Description:

Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be offered participation in an observational, prospective open label trial. Study duration will be 6 months.

Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying the prescreen requirements, the patient's information will be forwarded to the sub-investigator, who will confirm study eligibility and make the final determination verifying the diagnosis of GSM. Participants will be using commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. Patients will record dosing on the Intake Diary. Outcome measures will include:

Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire will also be used for sexually active patients at the same time points. This is an exploratory investigation. A planned paired T test will be applied to analyze the outcome and regroup after data has been collected on the first 14 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Female

2. Postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS)

3. Have self-identified GSM signs and objective symptoms on baseline screening

4. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.

5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility.

Exclusion Criteria:

1. Use of any estrogen containing product within 4 weeks prior to screening

2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy

3. Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.

4. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Congenital Abnormalities
• Dyspareunia
• Dysuria
• Genitourinary Abnormality
• Urinary Tract Infections
• Urogenital Abnormalities
• Vaginal Abnormality

Intervention

Combination Product:
• Replens and coconut oil

Locations

Country	Name	City	State
United States	Alta Bates Summit Medical Center	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Alta Bates Summit Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Davila GW, Singh A, Karapanagiotou I, Woodhouse S, Huber K, Zimberg S, Seiler J, Kopka SL. Are women with urogenital atrophy symptomatic? Am J Obstet Gynecol. 2003 Feb;188(2):382-8. — View Citation

Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b01 — View Citation

Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281. — View Citation

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Bérubé R, Bélanger P, Berger L, Gilbert L, Martel C, Balser J. Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration. Menopause. 2009 Sep-Oct;16(5):897-906. doi: 10.1097/gme.0b013e31819e8930. — View Citation

Larmo PS, Yang B, Hyssälä J, Kallio HP, Erkkola R. Effects of sea buckthorn oil intake on vaginal atrophy in postmenopausal women: a randomized, double-blind, placebo-controlled study. Maturitas. 2014 Nov;79(3):316-21. doi: 10.1016/j.maturitas.2014.07.010. Epub 2014 Jul 21. — View Citation

Nachtigall LE. Comparative study: Replens versus local estrogen in menopausal women. Fertil Steril. 1994 Jan;61(1):178-80. — View Citation

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of GSM signs and/or symptoms	To show improvement of GSM signs and/or symptoms at month 1 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.	1 month
Primary	Improvement of GSM signs and/or symptoms	To show improvement of GSM signs and/or symptoms at month 3 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.	3 months
Primary	Improvement of GSM signs and/or symptoms	To show improvement of GSM signs and/or symptoms at month 6 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.	6 months
Secondary	Sexual health of breast cancer survivors who are sexually active who are enrolled in this study	This study will investigate the sexual health of breast cancer survivors who are sexually active and using Replens™, Preseed™, coconut oil, or the patient's personal lubricant of choice prior to intercourse by the FSFI (Female Sexual Function Index) questionnaire. The percent change, from baseline to 6 months, in painful sexual activity will be explored.	6 months

External Links

•   A Multicenter Epidemiological Observational Prospective Study Of Vaginal Atrophy And Quality Of Life In Menopausal Women.
•   Guidance For Industry: Estrogen And Estrogen/Progestin Drug Products To Treat Vasomotor Symptoms And Vulvar And Vaginal Atrophy Symptoms--Recommendations For Clinical Evaluation
•   Long Term Non Hormonal Treatment of Vaginal Dryness.
•   The Female Sexual Function Index (FSFI): A Multidimensional Self-Rerpot Instrument for the Assessment of Female Sexual Function.