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

• Status: Unknown status
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo

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