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ContraceptionPhase 3NCT00884260

GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

A Phase 3 study testing Levonorgestrel IUS (LCS, BAY86-5028) in people with Contraception, run by Bayer at 25 sites in 3 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 assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Levonorgestrel IUS (LCS, BAY86-5028)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
918 participants
Where
25 sitesin 3 countries
Study dates
Apr 2009to Jun 2013
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
  • Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
  • Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
  • Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Who cannot join

  • Known or suspected pregnancy or is lactating.
  • Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.
  • Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.
  • History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
  • Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.
  • Abnormal uterine bleeding of unknown origin.
Show all 15Show fewer
  • Any genital infection (until successfully treated).
  • History of, or current, pelvic inflammatory disease
  • Congenital or acquired uterine anomaly.
  • Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
  • History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
  • Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
  • Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
  • Clinically significant ovarian cyst(s)
  • Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

China16 sites

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100191

  • Study site

    Beijing, 100730

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chongqing, 400010

  • Study site

    Chongqing, 400042

  • Study site

    Dalian, Liaoning, 116011

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Jinan, Shandong

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanjing, Jiangsu, 210009

  • Study site

    Nanjing, Jiangsu

  • Study site

    Shanghai, 200011

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200127

  • Study site

    Wuhan, Hubei, 430030

Other trials in China

South Korea5 sites

  • Study site

    Seoul, Korea, 100-380

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 138-736

  • Study site

    Sungnam-si, Gyeonggido, 463-712

Other trials in South Korea

Australia4 sites

  • Study site

    Ashfield, New South Wales, 2031

  • Study site

    Herston, Queensland, 4029

  • Study site

    Parkville, Victoria, 3052

  • Study site

    Subiaco, Western Australia, 6008

Other trials in Australia

About this study

Official title: Multi-center, Open Label, Single Arm Study to Assess Efficacy, Safety, Bleeding Pattern and Pharmacokinetics of the Ultra Low Dose Levonorgestrel Intrauterine Contraceptive System (LCS) for a Maximum of 3 Years in Women 18 to 40 Years of Age

The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.

Conditions
Contraception
Being tested
Levonorgestrel IUS (LCS, BAY86-5028)
Keywords
Contraception, Intrauterine contraception system

What participants receive

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

  • Levonorgestrel IUS (LCS, BAY86-5028)Drug

    In Vitro release rate: 12µg LNG/24h

Study groups in NCT00884260
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Levonorgestrel IUS (LCS, BAY86-5028)

What is being measured

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

  1. Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.

    Measured: 3 years

Secondary outcomes (4)

  1. LCS expulsion rate

    Measured: 3 years

  2. Discontinuation rates

    Measured: 3 years

  3. Adverse events

    Measured: 3 years

  4. Laboratory tests

    Measured: 3 years

Timeline

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

  1. First posted20 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
918 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00884260
Sponsor's protocol ID
91775
Other IDs
MAGIC, 311966
Status last verified
Aug 2014
First submitted
16 Apr 2009
Last updated
21 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel IUS (LCS, BAY86-5028) in people with Contraception, run by Bayer at 25 sites in 3 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 4 inclusion and 15 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China, South Korea, Australia. 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?

Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. (time frame: 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 NCT00884260.

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 21 Aug 2014.

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