AzTrials
AzTrials

PostmenopausePhase 3NCT00522873

Endometrial Safety Study

A Phase 3 study testing 0.25mg DRSP / 0.5mg E2 (BAY86-4891) and 0.5mg NETA / 1.0mg E2 (Activella) in people with Postmenopause, run by Bayer at 59 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium). Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Postmenopause
What is being tested?
0.25mg DRSP / 0.5mg E2 (BAY86-4891) and 0.5mg NETA / 1.0mg E2 (Activella)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
662 participants
Where
59 sitesin 8 countries
Study dates
Aug 2007to Aug 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
  • Non-hysterectomized women.

Who cannot join

  • Usual exclusion criteria for hormone therapy apply.

Trial locations and contacts

59 sites in 8 countries.

59 sites in 8 countries

United States17 sites

  • Study site

    Amite, Louisiana, 70422

  • Study site

    Boise, Idaho, 83704

  • Study site

    Boynton Beach, Florida, 33437

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Clearwater, Florida, 33759

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Denver, Colorado, 80218

  • Study site

    Greenwood Village, Colorado, 80111

  • Study site

    Las Vegas, Nevada, 89122

  • Study site

    Marrero, Louisiana, 70072

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Richmond, Virginia, 23294

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92108

  • Study site

    Seattle, Washington, 98105

Other trials in United States

Austria14 sites

  • Study site

    Bregenz, Vorarlberg, 6900

  • Study site

    Fürstenfeld, Styria, 8280

  • Study site

    Innsbruck, 6020

  • Study site

    Klagenfurt, 9020

  • Study site

    Mödling, Lower Austria, 2340

  • Study site

    Mürzzuschlag, 8680

  • Study site

    Sankt Pölten, 3100

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1060

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1200

  • Study site

    Wiener Neustadt, Lower Austria, 2700

  • Study site

    Wörgl, Tyrol, 6300

  • Study site

    Zeltweg, 8740

Other trials in Austria

Italy8 sites

  • Study site

    Bologna, 40138

  • Study site

    Cagliari, 09124

  • Study site

    Modena, 41124

  • Study site

    Novara, 28100

  • Study site

    Parma, 43100

  • Study site

    Pisa, 56126

  • Study site

    Sassari, 07100

  • Study site

    Siena, 53100

Other trials in Italy

Russia5 sites

  • Study site

    Moscow, 117415

  • Study site

    Moscow, 177997

  • Study site

    Moskva, 101000

  • Study site

    Moskva, 113093

  • Study site

    Moskva, 117997

Other trials in Russia

Argentina4 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1117ABH

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB

  • Study site

    Lanús Oeste, Buenos Aires, 1824

  • Study site

    San Isidro, Buenos Aires, B1642CLN

Other trials in Argentina

Brazil4 sites

  • Study site

    Curitiba, Paraná, 80030-220

  • Study site

    Goiânia, Goiás, 74175-080

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Study site

    São Paulo, São Paulo, 04062-003

Other trials in Brazil

Mexico4 sites

  • Study site

    México, 06700

  • Study site

    Mexico City, Mexico City

  • Study site

    México, D.F., 14050

  • Study site

    Monterrey, 64460

Other trials in Mexico

Denmark3 sites

  • Study site

    Aalborg, 9000

  • Study site

    Ballerup Municipality, 2750

  • Study site

    Vejle, 7100

Other trials in Denmark

About this study

Official title: A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Conditions
Postmenopause
Being tested
0.25mg DRSP / 0.5mg E2 (BAY86-4891), 0.5mg NETA / 1.0mg E2 (Activella)
Keywords
Postmenopausal Symptoms e.g., Hot flushes, Sweating episodes, Vaginal dryness
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.25mg DRSP / 0.5mg E2 (BAY86-4891)Drug

    One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).

  • 0.5mg NETA / 1.0mg E2 (Activella)Drug

    One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).

Study groups in NCT00522873
Study groupRoleWhat they receive
0.25mg DRSP / 0.5mg E2 (BAY86-4891)ExperimentalOne capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
Receives: Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
0.5mg NETA / 1.0mg E2 (Activella)Active comparatorOne capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
Receives: Drug: 0.5mg NETA / 1.0mg E2 (Activella)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)

    The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.

    Measured: Up to one year

Secondary outcomes (2)

  1. Number of Participants With Amenorrhea During Month 1 to 3 of Treatment

    The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.

    Measured: Month 1 to Month 3

  2. Number of Participants With Amenorrhea During Month 10 to 12 of Treatment

    The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.

    Measured: Month 10 to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
662 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522873
Sponsor's protocol ID
91508
Other IDs
2006-006199-39, 310523
Status last verified
Dec 2014
First submitted
29 Aug 2007
Last updated
31 Dec 2014
Data monitoring committee
No

Publications

  • Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17beta-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11.

    PubMed 23531117

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0.25mg DRSP / 0.5mg E2 (BAY86-4891) and 0.5mg NETA / 1.0mg E2 (Activella) in people with Postmenopause, run by Bayer at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Austria, Italy, Russia, Argentina and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment) (time frame: Up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in