NCT00356447

Brief Summary

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2006

Geographic Reach
1 country

9 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

1.4 years

First QC Date

July 25, 2006

Last Update Submit

September 30, 2014

Conditions

Vasomotor Symptoms

Outcome Measures

Primary Outcomes (2)

  • Frequency of hot flushes

    From baseline to week 16

  • Change in intensity of hot flushes

    From baseline to week 16

Secondary Outcomes (3)

  • Change in other climacteric symptoms

    From baseline to week 16

  • Vaginal Bleeding pattern

    From baseline to week 16

  • Global clinical impression

    From baseline to week 16

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Estradiol/DRSP (Angeliq, BAY86-4891)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Estradiol/DRSP (Angeliq, BAY86-4891)DRUG

Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.

Arm 1
PlaceboDRUG

Same administration.

Arm 2

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese postmenopausal women with moderate to severe vasomotor symptoms

You may not qualify if:

  • History of steroid hormone dependent malignant disease
  • Known or suspected malignant or premalignant disease
  • Current or history of severe heart, liver, renal, psychiatric disease
  • Hyperlipemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Wuhan, Hubei, 430032, China

Location

Unknown Facility

Nanjing, Jiangsu, 210029, China

Location

Unknown Facility

Jinan, Shandong, 250012, China

Location

Unknown Facility

Beijing, 100020, China

Location

Unknown Facility

Beijing, 100034, China

Location

Unknown Facility

Beijing, 100083, China

Location

Unknown Facility

Beijing, 100730, China

Location

Unknown Facility

Chongqing, 400010, China

Location

Unknown Facility

Shanghai, 200011, China

Location

MeSH Terms

Interventions

estradiol-drospirenone combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

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

July 25, 2006

First Posted

July 26, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

CN(9)