Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Pelvic Organ Prolapse Clinical Trial

Official title:

Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032848
• Other study ID #: 23286013.7.0000.0096
• Secondary ID: 475.622
• Status: Completed
• Phase: Phase 4
• Start date: November 26, 2013
• Est. completion date: December 26, 2016

Study information

• Verified date: April 2019
• Source: Universidade Federal do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 26, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• post menopause women

• normal oncotic cytology and mammogram

• any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria:

• vaginal bleeding

• hormonal replacement on the past three months

• renal or hepatic desease

• porfiria

• past venous thromboembolism; ulcerated prolapse

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Endometrial Hyperplasia
• Hyperplasia
• Pelvic Organ Prolapse
• Prolapse
• Vaginitis
• Vaginitis Atropic

Intervention

Drug:
• Conjugated Estrogen
use of 1 gram per day
• Promestriene
use of 1 gram per day
• Estriol
use of 1 gram per day
• Vaginal Moisturizer - Cream
use of 1 gram per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Paraná

References & Publications (1)

Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the histopathological effects on endometrium after each treatment	Compare the histopathological results after treatment on each group and among each other	48 days
Primary	Compare the endometrial thickness measured by ultrassound after each treatment	Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other	48 days
Secondary	Evaluate the changes of maturation index (Meisels Index) after each treatement	Compare the changes on Meisels Index after each treatment and among each other	48 days
Secondary	Evaluate the changes on climacteric complaints after each treatment	Compare the changes on systemic and genital complaints after each treatment, and among each other	48 days