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

NCT03116022 | Completed Phase 1 DMC

• 1 other identifier: 62443916.5.0000.5440
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia; Menopause; Sexual Dysfunction

Keywords

menopause; sexual dysfunction; coital pain; vagina

Outcome Measures

Primary Outcomes (1)

• Improvement in pain score after estriol use

  Number of women with lower score of pain assessed by the McGill Pain Questionnaire

  baseline and 12 weeks

Secondary Outcomes (11)

• Number of participants with risk for sexual dysfunction after estriol use

  baseline and week 12

• Number of participants with risk for anxiety after estriol use

  baseline and week 12

• Number of participants with risk for depression after estriol use

  baseline and week 12

• Reduction of de degree of coital pain

  baseline and week 12

• Variation in serum levels of estriol after estriol use

  Assessment of serum concentration of estriol at baseline and week 12.

Study Arms (3)

proximal estriol group (PEG )

ACTIVE COMPARATOR

This arm is composed of women using estriol 1 mg / 1g in the proximal third of vagina every other night

Drug: Estriol

distal estriol group (DEG)

EXPERIMENTAL

This arm is composed of women using estriol 1 mg / 1g in the distal third of the vagina every other night

Drug: Distal estriol

Control group (CG)

PLACEBO COMPARATOR

This arm is composed of women using vaginal gel lubricant base water during intercourse

Drug: Vaginal Gel

Interventions

Estriol DRUG

Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks

Also known as: PEG

proximal estriol group (PEG )

Distal estriol DRUG

Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks

Also known as: DEG

distal estriol group (DEG)

Vaginal Gel DRUG

Women using a base water gel lubricant during intercourse

Also known as: CG

Control group (CG)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (11)

• Lovejoy TI, Turk DC, Morasco BJ. Evaluation of the psychometric properties of the revised short-form McGill Pain Questionnaire. J Pain. 2012 Dec;13(12):1250-7. doi: 10.1016/j.jpain.2012.09.011.

  PMID: 23182230 BACKGROUND

• Varoli FK, Pedrazzi V. Adapted version of the McGill Pain Questionnaire to Brazilian Portuguese. Braz Dent J. 2006;17(4):328-35. doi: 10.1590/s0103-64402006000400012.

  PMID: 17262148 RESULT

• Weisberg E, Ayton R, Darling G, Farrell E, Murkies A, O'Neill S, Kirkegard Y, Fraser IS. Endometrial and vaginal effects of low-dose estradiol delivered by vaginal ring or vaginal tablet. Climacteric. 2005 Mar;8(1):83-92. doi: 10.1080/13697130500087016.

  PMID: 15804736 RESULT

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 RESULT

• Resplande J, Gholami SS, Graziottin TM, Rogers R, Lin CS, Leng W, Lue TF. Long-term effect of ovariectomy and simulated birth trauma on the lower urinary tract of female rats. J Urol. 2002 Jul;168(1):323-30.

  PMID: 12050564 RESULT

• 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 RESULT

• Simon JA, Maamari RV. Ultra-low-dose vaginal estrogen tablets for the treatment of postmenopausal vaginal atrophy. Climacteric. 2013 Aug;16 Suppl 1:37-43. doi: 10.3109/13697137.2013.807606.

  PMID: 23848490 RESULT

• Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2003;(4):CD001500. doi: 10.1002/14651858.CD001500.

  PMID: 14583935 RESULT

• Ting AY, Blacklock AD, Smith PG. Estrogen regulates vaginal sensory and autonomic nerve density in the rat. Biol Reprod. 2004 Oct;71(4):1397-404. doi: 10.1095/biolreprod.104.030023. Epub 2004 Jun 9.

  PMID: 15189832 RESULT

• Lara LA, Useche B, Ferriani RA, Reis RM, de Sa MF, de Freitas MM, Rosa e Silva JC, Rosa e Silva AC. The effects of hypoestrogenism on the vaginal wall: interference with the normal sexual response. J Sex Med. 2009 Jan;6(1):30-9. doi: 10.1111/j.1743-6109.2008.01052.x.

  PMID: 19170834 RESULT

• Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

  PMID: 37619252 DERIVED

MeSH Terms

Conditions

Dyspareunia; Sexual Dysfunction, Physiological

Interventions

Estriol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• lucia a Silva Lara, PhD

  Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D. Gynecology & Obstetrics, Sexual Health.

Model Details: we compared three groups: women using estriol in the proximal vagina wall, women using estriol in the distal vagina wall, and women using gel lubricant

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 14, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)