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Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial


Phase 3
20 Years
60 Years
Open (Enrolling)
Female
Sexual Dysfunction, Breast Cancer Survivors

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Trial Information

Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial


Study scheme

- study arm: apply lactate-containing lubricants at the time of sexual intercourse and
before sleep at least 3 times per a week for 8 weeks

- control arm: placebo apply

Outcome measures

- Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk

- vaginal maturation index: at 0 wk and 8 wk

- vaginal pH: at 0 wk and 8 wk


Inclusion Criteria:



- breast cancer survivors over 20 years-old

- premenopausal at the time of diagnosis

- treated with operation and chemotherapy

- newly developed dyspareunia after cancer treatment

Exclusion Criteria:

- recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)

- depression or other psychological problems

- active vaginal infection

- evidence of cancer recurrence

- previously use of lactate-containing lubricants

- other chronic diseases which severely disturb the sexual life

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

change of FSFI-20 (especially, dyspareunia score) compared with baseline score

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Myong Jae Jeon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

SNUH 0905-037-281

NCT ID:

NCT00981305

Start Date:

September 2009

Completion Date:

July 2013

Related Keywords:

  • Sexual Dysfunction
  • Breast Cancer Survivors
  • dyspareunia
  • breast cancer
  • sexual dysfunction
  • vaginal lubricant
  • Breast Neoplasms
  • Sexual Dysfunctions, Psychological

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