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

Primary Purpose

Genitourinary Abnormality, Breast Cancer Female, Vaginal Abnormality

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Replens and coconut oil

About this trial

This is an interventional treatment trial for Genitourinary Abnormality focused on measuring breast cancer survivor, postmenopausal, dysuria, dyspareunia, vaginal dryness, urinary tract infections, urinary frequency, urinary urgency, genital burning, genital itching, genital dryness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Alta Bates Summit Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Replens and coconut oil

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03185169

First Posted

May 26, 2017

Last Updated

July 23, 2018

Sponsor

Alta Bates Summit Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03185169

Brief Title

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

Acronym

GSM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Study design change required protocol/ICF changes, deemed more appropriate to terminate study and apply knowledge gained to potential future study design

Study Start Date

November 18, 2016 (Actual)

Primary Completion Date

July 23, 2018 (Actual)

Study Completion Date

July 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alta Bates Summit Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Observational, prospective open label trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Replens and coconut oil

Arm Type

Other

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Replens and coconut oil

Primary Outcome Measure Information:

Title

Improvement of GSM signs and/or symptoms

Description

Time Frame

1 month

Title

Improvement of GSM signs and/or symptoms

Description

Time Frame

3 months

Title

Improvement of GSM signs and/or symptoms

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uma Suryadevara, MD

Organizational Affiliation

Alta Bates Summit Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alta Bates Summit Medical Center

City

Berkeley

State/Province

California

ZIP/Postal Code

94704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24983271

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.

Results Reference

background

PubMed Identifier

12592244

Citation

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.

Results Reference

background

PubMed Identifier

25104582

Citation

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.

Results Reference

background

PubMed Identifier

19436226

Citation

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.

Results Reference

background

PubMed Identifier

8293835

Citation

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.

Results Reference

background

PubMed Identifier

10782451

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. doi: 10.1080/009262300278597.

Results Reference

background

PubMed Identifier

23481118

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.0b013e318282600b.

Results Reference

result

Links:

URL

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071643.pdf

Description

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

URL

https://www.womenshealthcaresolutions.com/assets/pdf/Postmenopausal_Vaginal_Atrophy.pdf

Description

A Multicenter Epidemiological Observational Prospective Study Of Vaginal Atrophy And Quality Of Life In Menopausal Women.

URL

https://www.womenshealthcaresolutions.com/assets/pdf/Vaginal_Dryness_and_Quality_of_Life_in_Menopausal_Women.pdf

Description

The Female Sexual Function Index (FSFI): A Multidimensional Self-Rerpot Instrument for the Assessment of Female Sexual Function.

URL

https://www.womenshealthcaresolutions.com/assets/pdf/Long_Term_Non-Hormonal_Treatment_of_Vaginal_Dryness.pdf

Description

Long Term Non Hormonal Treatment of Vaginal Dryness.

Learn more about this trial

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

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