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ContraceptionPhase 3NCT01434160

LCS12 Adolescent Study

A Phase 3 study testing Skyla (Levonorgestrel, BAY86-5028) in people with Contraception, run by Bayer at 41 sites in 8 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 study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be… Read more about this study

Who is it for?
Ages 12 to 17 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Skyla (Levonorgestrel, BAY86-5028)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
41 sitesin 8 countries
Study dates
Sep 2011to May 2015
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 12 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The subject has signed and dated the informed consent form (ICF)
  • The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit
  • The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days)
  • In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm)
  • Has clinically normal safety laboratory results
  • The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system)
  • The subject is willing and able to attend the scheduled study visits and to comply with the study procedures

Who cannot join

  • Known or suspected pregnancy or is lactating
  • Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1
  • History of ectopic pregnancies
  • Infected abortion or postpartum endometritis less than 3 months before Visit 1
  • Abnormal uterine bleeding of unknown origin
  • Any lower genital tract infection (until successfully treated)
  • Acute or history of recurrent pelvic inflammatory disease
  • Congenital or acquired uterine anomaly

Trial locations and contacts

41 sites in 8 countries.

41 sites in 8 countries

Germany10 sites

  • Study site

    Blankenburg, Saxony-Anhalt, 38889

  • Study site

    Cologne, North Rhine-Westphalia, 50931

  • Study site

    Dippoldiswalde, Saxony, 01744

  • Study site

    Dresden, Saxony, 01169

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Geseke, North Rhine-Westphalia, 59590

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 21073

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 22587

  • Study site

    Leipzig, Saxony, 04207

  • Study site

    Leipzig, Saxony, 04299

Other trials in Germany

Netherlands7 sites

  • Study site

    Alkmaar, 1817 MS

  • Study site

    Almere Stad

  • Study site

    Den Helder, 1780 AT

  • Study site

    Enschede

  • Study site

    Heerlen

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Tilburg

Other trials in Netherlands

Austria5 sites

  • Study site

    Bregenz, 6900

  • Study site

    Sankt Pölten, Lower Austria, 3100

  • Study site

    Vienna, 1070

  • Study site

    Voitsberg, 8570

  • Study site

    Zeltweg, 8740

Other trials in Austria

Belgium5 sites

  • Study site

    Antwerp, 2018

  • Study site

    Bruxelles - Brussel, 1020

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Charleroi, 6000

  • Study site

    Leuven, 3000

Other trials in Belgium

Finland5 sites

  • Study site

    Helsinki, 00100

  • Study site

    Helsinki, 00610

  • Study site

    Kuopio, 70110

  • Study site

    Oulu, 90100

  • Study site

    Oulu, 90220

Other trials in Finland

Sweden4 sites

  • Study site

    Gothenburg, 411 18

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 171 76

  • Study site

    Uppsala, 75185

Other trials in Sweden

Denmark3 sites

  • Study site

    Århus C, DK-8000

  • Study site

    København NV, DK-2400

  • Study site

    København S, 2300

Other trials in Denmark

Norway2 sites

  • Study site

    Fornebu, 1364

  • Study site

    Sellebakk, 1653

Other trials in Norway

About this study

Official title: Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase

The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study.

Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months.

The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.

Conditions
Contraception
Being tested
Skyla (Levonorgestrel, BAY86-5028)
Keywords
Intrauterine, contraception, adolescent

What participants receive

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

  • Skyla (Levonorgestrel, BAY86-5028)Drug

    Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.

Study groups in NCT01434160
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Skyla (Levonorgestrel, BAY86-5028)

What is being measured

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

  1. Number of adverse events reported by study subjects

    Measured: 12 months treatment period

  2. Portion of subjects reporting adverse events

    Measured: 12 months treatment period

Secondary outcomes (6)

  1. Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)

    Measured: 12 months treatment period

  2. Pearl index

    Measured: 12 months treatment period

  3. Bleeding patterns collected from patients' diary

    Measured: 12 months treatment period

  4. Concentration of Levonorgestrel in serum

    Measured: At 1, 3, 6, 9 or 12 months

  5. Concentration of sex hormone binding globulin in serum

    Measured: At 1, 3, 6, 9 or 12 months

  6. Discontinuation rate

    Measured: 12 months treatment period

Timeline

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

  1. First posted14 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJun 2013
  4. Study completionMay 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01434160
Sponsor's protocol ID
14371
Other IDs
2011-002065-37
Status last verified
Jul 2015
First submitted
13 Sep 2011
Last updated
27 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Gemzell-Danielsson K, Buhling KJ, Dermout SM, Lukkari-Lax E, Montegriffo E, Apter D. A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents. Contraception. 2016 Jun;93(6):507-12. doi: 10.1016/j.contraception.2016.02.004. Epub 2016 Feb 9.

    PubMed 26872720

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Skyla (Levonorgestrel, BAY86-5028) in people with Contraception, run by Bayer at 41 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 7 inclusion and 8 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Germany, Netherlands, Austria, Belgium, Finland 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?

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?

Number of adverse events reported by study subjects (time frame: 12 months treatment period). The study lists 2 primary outcomes in all. 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 NCT01434160, 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 27 Jul 2015.

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