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Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women

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ClinicalTrials.gov Identifier: NCT03116022
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Lucia Alves da Silva Lara, University of Sao Paulo

Brief Summary:
Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.

Condition or disease Intervention/treatment Phase
Dyspareunia Menopause Sexual Dysfunction Drug: Estriol Drug: Distal estriol Drug: Vaginal Gel Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Estriol at Distal Third of the Vaginal Wall Relieving Coital Pain in Women After Menopause: a Randomized, Blinded and Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Estriol

Arm Intervention/treatment
Active Comparator: proximal estriol group (PEG )
This arm is composed of women using estriol 1 mg / 1g in the proximal third of vagina every other night
Drug: Estriol
Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks
Other Name: PEG

Experimental: distal estriol group (DEG)
This arm is composed of women using estriol 1 mg / 1g in the distal third of the vagina every other night
Drug: Distal estriol
Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks
Other Name: DEG

Placebo Comparator: Control group (CG)
This arm is composed of women using vaginal gel lubricant base water during intercourse
Drug: Vaginal Gel
Women using a base water gel lubricant during intercourse
Other Name: CG




Primary Outcome Measures :
  1. Improvement in pain score after estriol use [ Time Frame: baseline and 12 weeks ]
    Number of women with lower score of pain assessed by the McGill Pain Questionnaire


Secondary Outcome Measures :
  1. Number of participants with risk for sexual dysfunction after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Female Sexual Function Index (FSFI) total score ≤ 26.55 before after estriol use

  2. Number of participants with risk for anxiety after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Hospital Anxiety Scale total score ≥ 9 for anxiety after estriol treatment

  3. Number of participants with risk for depression after estriol use [ Time Frame: baseline and week 12 ]
    Comparison will be made between the total number of subjects with Hospital Anxiety Scale total score ≥ 9 for anxiety after estriol treatment

  4. Reduction of de degree of coital pain [ Time Frame: baseline and week 12 ]
    Number of women with lower degree of pain accessed by the Analogic Visual Scale graded from 0 to 10, with 0 being no pain and 10 being the maximum level of pain

  5. Variation in serum levels of estriol after estriol use [ Time Frame: Assessment of serum concentration of estriol at baseline and week 12. ]
    Number of women with abnormal laboratory values of estriol after estriol use assessed by chemiluminescence

  6. Variation in serum levels of follicle-stimulating hormone after estriol use [ Time Frame: Assessment of serum concentration of follicle-stimulating hormone at baseline and week 12. ]
    Number of women with abnormal laboratory values of follicle-stimulating hormone after estriol use assessed by chemiluminescence

  7. Variation in serum levels of thyroid-stimulating hormone after estriol use [ Time Frame: Assessment of serum concentration of thyroid-stimulating hormone at baseline and week 12. ]
    Number of women with abnormal laboratory values of thyroid-stimulating hormone after estriol use assessed by chemiluminescence

  8. Number of participants with adverse events that are related to estriol use [ Time Frame: Assessment of laboratory values at baseline and week 12. Adverse events assessed each 4 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. ]
    Variation in serum levels of estriol, follicle-stimulating hormone, and thyroid-stimulating hormone will be performed by chemiluminescence. Adverse events will be assessed clinically by telephone

  9. Variation in blood glucose after estriol use [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with abnormal laboratory values for blood glucose determined by the glucose oxidase-phenol (GOD-POD) method

  10. Variation in weight after estriol use Weight [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with weight gain after estriol use

  11. Variation in body mass index (BMI) after estriol use [ Time Frame: Assessed at baseline and on week 12 ]
    Number of women with modified BMI after estriol use



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with a clinical diagnosis of menopause
  • FSH> 40 milli-International unit (mIU/ml)
  • Having sex including penetration of penis into vagina
  • Pain during penetration
  • Active sexual partners
  • Stable relationship.

Exclusion Criteria:

  • Previous use of steroids in genital area in the last month
  • Thromboembolism history
  • Renal insufficiency
  • Cholestatic jaundice
  • Degenerative vulvar pathology
  • Breast cancer
  • Endometrial cancer
  • Vulvar cancer
  • Vaginal cancer history
  • Prior radiotherapy to the genital region
  • Smoking
  • Acute urogenital infections
  • Vulvovaginitis
  • Urinary tract infection
  • Genital herpes
  • Genital prolapse grades II, III and IV by Baden Walker
  • Systemic hormonal therapy in the last three months
  • Use of antidepressants drugs
  • Diabetes
  • Thyroid disorder
  • Cognitive restrictions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116022


Contacts
Contact: Sérgio H Pires Okano, M.D. +5516988120532 sergio.okano@usp.br
Contact: Lucia A Silva Lara, M.D, phD +551636021000 luciaalvess@yahoo.com.br

Locations
Brazil
Hospital das Clínicas de Ribeirão Preto Recruiting
Ribeirão Preto, SP, Brazil, 14049-900
Contact: Sergio Okano, MD    16988120532      
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: lucia a Silva Lara, M.D, phD Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

Publications of Results:

Other Publications:
Responsible Party: Lucia Alves da Silva Lara, M.D, Ph.D. Gynecology & Obstetrics, Sexual Health., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03116022     History of Changes
Other Study ID Numbers: 62443916.5.0000.5440
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lucia Alves da Silva Lara, University of Sao Paulo:
menopause
sexual dysfunction
coital pain
vagina

Additional relevant MeSH terms:
Dyspareunia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders