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ContraceptionPhase 2NCT00185380

Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

A Phase 2 study testing Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C) and Levonorgestrel IUS (Mirena, BAY86-5028) in people with Contraception, run by Bayer at 35 sites in 5 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 investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). Read more about this study

Who is it for?
Ages 21 to 40 years, women only
Conditions the study is for
Contraception
What is being tested?
Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C) and Levonorgestrel IUS (Mirena, BAY86-5028)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
742 participants
Where
35 sitesin 5 countries
Study dates
Apr 2005to Dec 2008
Phase
Phase 2
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 21 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women with or without children and good general health and in need of contraception.
  • Regular menstrual cycle without hormonal contraceptives.

Who cannot join

  • Pregnant or lactating.
  • Last delivery or abortion less than 12 weeks ago.
  • Previous pregnancies outside the womb.
  • Previous pelvic infections.
  • Abnormal bleeding.
  • Abnormal uterine cavity.
Show all 10Show fewer
  • Climacteric signs.
  • Genital cancer.
  • Liver diseases.
  • Alcoholism or drug abuse.

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

Finland14 sites

  • Study site

    Espoo, 02100

  • Study site

    Helsinki, 00100

  • Study site

    Joensuu, 80100

  • Study site

    Jyväskylä, 40620

  • Study site

    Kotka, 48100

  • Study site

    Kuopio, 70110

  • Study site

    Lahti, 15110

  • Study site

    Oulu, 90100

  • Study site

    Oulu, 90220

  • Study site

    Oulu, 90570

  • Study site

    Tampere, 33100

  • Study site

    Turku, 20100

  • Study site

    Turku, 20520

  • Study site

    Turku, 20540

Other trials in Finland

Sweden8 sites

  • Study site

    Gothenburg, 411 35

  • Study site

    Huddinge, 14186

  • Study site

    Kalmar, 39231

  • Study site

    Luleå, 972 33

  • Study site

    Norrköping, 602 22

  • Study site

    Örebro, 701 46

  • Study site

    Stockholm, S-171 76

  • Study site

    Umeå, 90185

Other trials in Sweden

Norway6 sites

  • Study site

    Drammen, 3001

  • Study site

    Elverum, 2403

  • Study site

    Kolbotn, 1411

  • Study site

    Larvik, 3264

  • Study site

    Oslo, 0309

  • Study site

    Trondheim, 7014

Other trials in Norway

Hungary4 sites

  • Study site

    Békéscsaba, 5600

  • Study site

    Eger, 3300

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szeged, 6725

Other trials in Hungary

United Kingdom3 sites

  • Study site

    Chesterfield, Derbyshire, S40 4TF

  • Study site

    Chesterfield, S40 1SX

  • Study site

    Sheffield, South Yorkshire, S1 2PJ

Other trials in United Kingdom

About this study

Official title: Multi-center, Open, Randomized, Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception.

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Read the detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Conditions
Contraception
Being tested
Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C), Levonorgestrel IUS (Mirena, BAY86-5028)

What participants receive

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

  • Levonorgestrel IUS (BAY86-5028, G04209B)Drug

    Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years

  • Levonorgestrel IUS (BAY86-5028, G04209C)Drug

    Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years

  • Levonorgestrel IUS (Mirena, BAY86-5028)Drug

    Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Study groups in NCT00185380
Study groupRoleWhat they receive
LCS12ExperimentalLevonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
Receives: Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
LCS16ExperimentalLevonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
Receives: Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
IUS20 (Mirena)Active comparatorLevonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

What is being measured

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

  1. Pearl Index

    The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Number of Subjects With Total or Partial Expulsions

    The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.

    Measured: Up to 3 years

  2. Bleeding Pattern by 90-day Reference Periods - Reference Period 1

    Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

    Measured: day 1 to day 90

  3. Bleeding Pattern by 90-day Reference Periods - Reference Period 2

    Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

    Measured: day 91 to day 180

  4. Bleeding Pattern by 90-day Reference Periods - Reference Period 3

    Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

    Measured: day 181 to day 270

  5. Bleeding Pattern by 90-day Reference Periods - Reference Period 4

    Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

    Measured: day 271 to day 360

  6. Bleeding Pattern by 90-day Reference Periods - Reference Period 12

    Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

    Measured: day 991 to day 1080

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionDec 2008
  4. Study completionDec 2008

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185380
Sponsor's protocol ID
91412
Other IDs
2004-002291-42, 308901, 2004
Status last verified
May 2015
First submitted
13 Sep 2005
Last updated
10 Jun 2015
Data monitoring committee
No

Publications

  • Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. doi: 10.1016/j.fertnstert.2011.12.003. Epub 2012 Jan 4.

    PubMed 22222193

  • Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.

    PubMed 24726226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C) and Levonorgestrel IUS (Mirena, BAY86-5028) in people with Contraception, run by Bayer at 35 sites in 5 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 10 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Finland, Sweden, Norway, Hungary, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Mar 2010). 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?

Pearl Index (time frame: Up to 3 years). 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 NCT00185380, 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 10 Jun 2015.

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