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ContraceptionPhase 3NCT01397097

LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study

A Phase 3 study testing LNG-IUS (BAY 86-5028) and 68 mg etonorgestrel implant for subdermal use (Nexplanon) in people with Contraception, run by Bayer at 43 sites in 6 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 primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Contraception
What is being tested?
LNG-IUS (BAY 86-5028) and 68 mg etonorgestrel implant for subdermal use (Nexplanon)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
43 sitesin 6 countries
Study dates
Sep 2011to Apr 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 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed and dated the informed consent
  • Healthy female subjects in need of contraception
  • Age: between 18 and 35 years (inclusive) at Screening visit
  • Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). HPV testing in subjects with ASCUS can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
  • History of regular cyclic menstrual periods as determined by subject's history, subject has regular menstrual cycles (length of cycle 21 - 35 days). (Subject's history while not using hormonal contraceptives is sufficient, no washout period is required).
  • Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Who cannot join

  • Pregnancy or currently lactating
  • Vaginal delivery, cesarean delivery or abortion within 6 weeks prior to Screening visit. Note: Postpartum LCS12 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.
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening visit.
  • Undiagnosed abnormal genital bleeding.
  • Acute lower genital tract infection (until successfully treated)
  • Acute or history of recurrent, pelvic inflammatory disease.
Show all 28Show fewer
  • Congenital or acquired uterine anomaly or any distortion of the uterine cavity (e.g. by fibroids) that, in the opinion of the investigator or designee, would cause problems during insertion, retention, or removal of LCS12. (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of uterine anomaly or any distortion of the uterine cavity, appropriate diagnostic measures should be taken prior to randomization)
  • History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
  • Clinically significant endometrial polyp(s) that, in the opinion of the investigator or designee, may interfere with the assessment of the bleeding profile during the study. (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of polyps, appropriate diagnostic measures should be taken prior to randomization.)
  • Has previously failed screening for this study
  • Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. The following are examples of such conditions or diseases:
  • Cardiovascular
  • Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris)
  • Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
  • Liver
  • Presence or history of liver tumors (benign or malignant)
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal
  • Jaundice and/or pruritus related to cholestasis (Gilbert's syndrome excepted)
  • History of cholestatic jaundice associated with pregnancy or previous COC use
  • Other diseases:
  • Malignant or premalignant disease (excluding melanoma)
  • History of migraine with focal neurologic symptoms
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Clinically significant ovarian cyst (defined as abnormal non-functional cysts) (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of a clinically significant cyst, appropriate diagnostic measures should be taken prior to randomization.)
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication
  • Other contraceptive methods:
  • Sterilization
  • Use of any long-acting injectable sex-hormone preparations within 10 months prior to the Randomization visit. The use of non study oral, vaginal, or transdermal hormonal contraception, intrauterine devices (IUDs) with or without hormonal release, and implants is prohibited during treatment.

Trial locations and contacts

43 sites in 6 countries.

43 sites in 6 countries

Sweden10 sites

  • Study site

    Gothenburg, 411 18

  • Study site

    Gothenburg, 416 64

  • Study site

    Linköping, 582 25

  • Study site

    Luleå, 972 33

  • Study site

    Malmö, 205 02

  • Study site

    Malmö, 217 44

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 171 76

  • Study site

    Uppsala, 75185

Other trials in Sweden

Finland9 sites

  • Study site

    Espoo, 02100

  • Study site

    Helsinki, 00100

  • Study site

    Helsinki, 00120

  • Study site

    Helsinki, 00260

  • Study site

    Kuopio, 70110

  • Study site

    Tampere, 33100

  • Study site

    Tampereen Yliopisto, 33014

  • Study site

    Turku, 20100

  • Study site

    Turku, 20540

Other trials in Finland

France8 sites

  • Study site

    Biarritz, 64200

  • Study site

    Bordeaux, 33000

  • Study site

    Marseille, 13005

  • Study site

    Quetigny, 21800

  • Study site

    Reims, 51092

  • Study site

    Schiltigheim, 67300

  • Study site

    Seclin, 59113

  • Study site

    Strasbourg, 67 000

Other trials in France

United Kingdom6 sites

  • Study site

    Cambridge, Cambridgeshire, CB5 8DT

  • Study site

    Leeds, West Yorkshire, LS2 9AE

  • Study site

    Liverpool, L20 5DQ

  • Study site

    London, London, SW10 9NH

  • Study site

    London, W12 0HS

  • Study site

    Sheffield, South Yorkshire, S1 2PJ

Other trials in United Kingdom

Australia5 sites

  • Study site

    Ashfield, New South Wales, 2031

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    North Adelaide, South Australia, 5006

  • Study site

    Parkville, Victoria, 3053

  • Study site

    Sydney, New South Wales, 2031

Other trials in Australia

Norway5 sites

  • Study site

    Elverum, 2403

  • Study site

    Haugesund, 5515

  • Study site

    Ski, 1400

  • Study site

    Straume, 5353

  • Study site

    Trondheim, 7014

Other trials in Norway

About this study

Official title: Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age

The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.

Conditions
Contraception
Being tested
LNG-IUS (BAY 86-5028), 68 mg etonorgestrel implant for subdermal use (Nexplanon)

What participants receive

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

  • LNG-IUS (BAY 86-5028)Drug

    LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years

  • 68 mg etonorgestrel implant for subdermal use (Nexplanon)Drug

    Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care.

Study groups in NCT01397097
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: LNG-IUS (BAY 86-5028)
Arm 2Active comparatorNot described
Receives: Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)

What is being measured

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

  1. Discontinuation rate by treatment group

    Measured: at 12 months

Secondary outcomes (3)

  1. Discontinuation rates by treatment group

    Measured: at 6 months and by reason at 6 and 12 months

  2. Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability

    Measured: at 6 and 12 months

  3. Pregnancy rate, as determined by Pearl index

    Measured: at 12 months

Timeline

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

  1. First posted19 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJun 2013
  4. Study completionApr 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397097
Sponsor's protocol ID
13363
Other IDs
2010-023911-32
Status last verified
Jul 2016
First submitted
18 Jul 2011
Last updated
25 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.

    PubMed 27016644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNG-IUS (BAY 86-5028) and 68 mg etonorgestrel implant for subdermal use (Nexplanon) in people with Contraception, run by Bayer at 43 sites in 6 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 6 inclusion and 28 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Sweden, Finland, France, United Kingdom, Australia and 1 more country. 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?

Discontinuation rate by treatment group (time frame: at 12 months). 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 NCT01397097, 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 25 Jul 2016.

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