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ContraceptionPhase 3NCT00624130

Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

A Phase 3 study testing Yasmin 20 and Mercilon in people with Contraception, run by Bayer at 17 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Yasmin 20 and Mercilon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
17 sitesin 4 countries
Study dates
Mar 2004to Jun 2005
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Who cannot join

  • Contraindications for using hormonal contraceptives

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Austria6 sites

  • Study site

    Horn, 3580

  • Study site

    Leibnitz, Styria, 8430

  • Study site

    Mödling, 2340

  • Study site

    Sankt Pölten, 3100

  • Study site

    Vienna, 1050

  • Study site

    Wörgl, 6300

Other trials in Austria

Finland4 sites

  • Study site

    Helsinki, 00100

  • Study site

    Helsinki, 00260

  • Study site

    Tampere, 33200

  • Study site

    Turku, 20101

Other trials in Finland

Lithuania4 sites

  • Study site

    Kaunas, 3042

  • Study site

    Kaunas, 3043

  • Study site

    Vilnius, 01118

  • Study site

    Vilnius, 2035

Other trials in Lithuania

Estonia3 sites

  • Study site

    Pärnu, 80010

  • Study site

    Talinn, 10145

  • Study site

    Tartu, 51003

Other trials in Estonia

About this study

Official title: Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Conditions
Contraception
Being tested
Yasmin 20, Mercilon
Keywords
Contraception,, Cycle control,, Bleeding pattern

What participants receive

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

  • Yasmin 20Drug

    Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

  • MercilonDrug

    Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Study groups in NCT00624130
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Yasmin 20
Arm 2Active comparatorNot described
Receives: Drug: Mercilon

What is being measured

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

  1. Cycle control and bleeding pattern

    Measured: 7 cycles

Secondary outcomes (6)

  1. Pearl index

    Measured: 7 cycles

  2. Laboratory tests

    Measured: Screening

  3. Adverse Events

    Measured: 7 cycles

  4. General Physical and gynecological examinations

    Measured: Screening

  5. Vital signs

    Measured: Screening, admission

  6. Body weight

    Measured: Screening, admission

Timeline

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

  1. First posted26 Feb 2008 (estimated)
  2. Study startMar 2004
  3. Study completionJun 2005

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00624130
Sponsor's protocol ID
91352
Other IDs
308020
Status last verified
Dec 2014
First submitted
18 Feb 2008
Last updated
31 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

    PubMed 21721590

  • Anttila L, Bachmann G, Hernadi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.

    PubMed 21277674

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Yasmin 20 and Mercilon in people with Contraception, run by Bayer at 17 sites in 4 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 17 sites in Austria, Finland, Lithuania, Estonia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cycle control and bleeding pattern (time frame: 7 cycles). 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 NCT00624130, which also lists 2 linked publications.

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.

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