NCT01695616

Brief Summary

The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

September 26, 2012

Last Update Submit

October 18, 2016

Conditions

Climacteric Syndrome

Outcome Measures

Primary Outcomes (1)

  • Menopause Rating Scale - MRS

    104 days

Secondary Outcomes (3)

  • Kuppperman-Blatt index

    90 days

  • MRS scale

    90 days

  • MENQOL

    90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients enrolled in this arm will take a tablet twice a day

Drug: Placebo

Passiflora incarnata and isoflavona combination

ACTIVE COMPARATOR

Patients enrolled in this arm will take a tablet twice a day

Drug: Active drug

Interventions

PlaceboDRUG
Placebo
Active drugDRUG
Passiflora incarnata and isoflavona combination

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female amenorrheic for at least one (1) year or surgical menopause since dosage of FSH ≥ 30 mIU / ml;
  • Age greater than or equal to 40 and less than or equal to 65 years;
  • Cytological examination colpo held at screening visit, Pap cytology classification with class I and II;
  • Line endometrial ≤ 8 mm by transvaginal ultrasound, performed at screening visit, in the case of subjects who have an intact uterus;

You may not qualify if:

  • History of severe liver or renal disease at the discretion of the investigator;
  • Hypertension stage III uncontrolled (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg);
  • Important cardiovascular disease such as coronary insufficiency or dilated cardiomyopathy advanced;
  • Using estrogens, progestins, steroid or hormone replacement therapy (HRT) in the last 3 months;
  • Estrogen-dependent neoplasia;
  • Thromboembolic disorders for less than one year of screening visit;
  • Anabolic drugs use or illicit drug use;
  • Hemoglobin \< 10 or \> 17 g / dL;
  • TSH \< 0, 550 or \> 4, 780 UUI / L;
  • FT4 \< 0.75 ηg / dL or \> 1.8 ηg / dL;
  • Patient that is chronically using MAO inhibitors (MAOIs) or levothyroxine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISBEM

São Paulo, São Paulo, 04062-003, Brazil

Location

MeSH Terms

Interventions

Bulk Drugs

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

BR(1)