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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
First received
Last updated
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
Health authority
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

Study Design


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
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