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

NCT03185169 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: GSM
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genitourinary Abnormality; Breast Cancer Female; Vaginal Abnormality; Urinary Tract Infections; Dyspareunia; Dysuria

Keywords

breast cancer survivor; postmenopausal; dysuria; dyspareunia; vaginal dryness; urinary tract infections; urinary frequency; urinary urgency; genital burning; genital itching; genital dryness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Sexual health of breast cancer survivors who are sexually active who are enrolled in this study

  6 months

Study Arms (1)

Replens and coconut oil

OTHER

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.

Combination Product: Replens and coconut oil

Interventions

Replens and coconut oil COMBINATION_PRODUCT

Replens and coconut oil

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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)
• Have self-identified GSM signs and objective symptoms on baseline screening
• Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
• 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.

You may not qualify if:

• Use of any estrogen containing product within 4 weeks prior to screening
• Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy
• Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.
• Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.

Sponsors & Collaborators

• Alta Bates Summit Medical Center: lead

Study Sites (1)

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

Location

Related Publications (7)

• 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.

  PMID: 24983271 BACKGROUND

• 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. doi: 10.1067/mob.2003.23.

  PMID: 12592244 BACKGROUND

• Larmo PS, Yang B, Hyssala 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.

  PMID: 25104582 BACKGROUND

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berube R, Belanger 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.

  PMID: 19436226 BACKGROUND

• Nachtigall LE. Comparative study: Replens versus local estrogen in menopausal women. Fertil Steril. 1994 Jan;61(1):178-80. doi: 10.1016/s0015-0282(16)56474-7.

  PMID: 8293835 BACKGROUND

• 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. doi: 10.1080/009262300278597.

  PMID: 10782451 BACKGROUND

• 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.0b013e318282600b.

  PMID: 23481118 RESULT

Related Links

• Guidance For Industry: Estrogen And Estrogen/Progestin Drug Products To Treat Vasomotor Symptoms And Vulvar And Vaginal Atrophy Symptoms--Recommendations For Clinical Evaluation

MeSH Terms

Conditions

Urogenital Abnormalities; Urinary Tract Infections; Dyspareunia; Dysuria

Interventions

Replens; Coconut Oil

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Urologic Diseases; Genital Diseases, Female; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Uma Suryadevara, MD

  Alta Bates Summit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Observational, prospective open label trial

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 14, 2017
• Study Start: November 18, 2016
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (1)