Estriol use at the entrance and inside of vagina improving coital pain in women after menopause

Use of estriol at distal third of the vaginal wall improving coital pain in women after menopause: a randomized, blinded and controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3y8v57

Enrollment

Unknown

Registered

2017-05-12

Start date

2017-05-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia

Interventions

Participants will be randomized into 3 groups: GEP, GED and GG. Each group will have 44 participants, which will undergo the use of the medication as described below for three months. Prior to the int

Drug

E02.319.283

Eligibility

Sex/Gender

Female

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women with a clinical diagnosis of menopause; FSH over 40 mIU/ml with a minimum age of 40 years old and and maximum age of 65 with sex including penetration of penis into vagina and complaining of pain during penetration, which appeared in peri or postmenopausal with active sexual partners and stable relationship.

Exclusion criteria

Exclusion criteria: Women will be excluded if previous use of steroids in genital area in the last month; thromboembolism history; renal insufficiency; cholestatic jaundice; degenerative vulvar pathology; breast, endometrial, vulvar and vaginal cancer history; prior radiotherapy to the genital region; smoking; acute urogenital infections (vulvovaginitis, urinary tract infection and genital herpes); genital prolapse grades II, III and IV by Baden Walker; systemic hormonal therapy in the last three months; in treatment of depression; suffering from diabetes, thyroid disorders or cognitive restrictions.

Design outcomes

Primary

Measure	Time frame
Improvement of the dyspareunia with estriol applied in the distal third of the vagina in relation to the group that applied the medication in the proximal third and control, evaluated by the application of FSFI and Visual Analog Pain Scale.	—

Secondary

Measure	Time frame
Undetectable blood level of Estriol with estriol applied to the distal third of the vagina, compared to the other groups, measured 3 months after the start of the intervention.	—

Countries

Brazil

Contacts

Public ContactSergio Pires Okano

Faculdade de Medicina de Ribeirão Preto

sergio.okano@usp.br+55 (16) 988120532

Outcome results

None listed

Source: REBEC (via WHO ICTRP)