NCT01397097

Brief 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. 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
766

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach
6 countries

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

July 18, 2011

Last Update Submit

July 22, 2016

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • Discontinuation rate by treatment group

    at 12 months

Secondary Outcomes (3)

  • Discontinuation rates by treatment group

    at 6 months and by reason at 6 and 12 months

  • Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability

    at 6 and 12 months

  • Pregnancy rate, as determined by Pearl index

    at 12 months

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: LNG-IUS (BAY 86-5028)

Arm 2

ACTIVE COMPARATOR
Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)

Interventions

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

Arm 1
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.

Arm 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Unknown Facility

Ashfield, New South Wales, 2031, Australia

Location

Unknown Facility

Sydney, New South Wales, 2031, Australia

Location

Unknown Facility

North Adelaide, South Australia, 5006, Australia

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Unknown Facility

Parkville, Victoria, 3053, Australia

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Unknown Facility

Nedlands, Western Australia, 6009, Australia

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Unknown Facility

Espoo, 02100, Finland

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Unknown Facility

Helsinki, 00100, Finland

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Unknown Facility

Helsinki, 00120, Finland

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Unknown Facility

Helsinki, 00260, Finland

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Unknown Facility

Kuopio, 70110, Finland

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Unknown Facility

Tampere, 33100, Finland

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Unknown Facility

Tampereen Yliopisto, 33014, Finland

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Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Turku, 20540, Finland

Location

Unknown Facility

Biarritz, 64200, France

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Unknown Facility

Bordeaux, 33000, France

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Unknown Facility

Marseille, 13005, France

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Unknown Facility

Quetigny, 21800, France

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Unknown Facility

Reims, 51092, France

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Unknown Facility

Schiltigheim, 67300, France

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Unknown Facility

Seclin, 59113, France

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Unknown Facility

Strasbourg, 67 000, France

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Unknown Facility

Elverum, 2403, Norway

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Unknown Facility

Haugesund, 5515, Norway

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Unknown Facility

Ski, 1400, Norway

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Unknown Facility

Straume, 5353, Norway

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Unknown Facility

Trondheim, 7014, Norway

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Unknown Facility

Gothenburg, 411 18, Sweden

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Unknown Facility

Gothenburg, 416 64, Sweden

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Unknown Facility

Linköping, 582 25, Sweden

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Unknown Facility

Luleå, 972 33, Sweden

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Unknown Facility

Malmo, 205 02, Sweden

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Unknown Facility

Malmo, 217 44, Sweden

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Unknown Facility

Örebro, 701 85, Sweden

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Unknown Facility

Stockholm, 118 83, Sweden

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Unknown Facility

Stockholm, 171 76, Sweden

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Unknown Facility

Uppsala, 75185, Sweden

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Unknown Facility

Cambridge, Cambridgeshire, CB5 8DT, United Kingdom

Location

Unknown Facility

London, London, SW10 9NH, United Kingdom

Location

Unknown Facility

Sheffield, South Yorkshire, S1 2PJ, United Kingdom

Location

Unknown Facility

Leeds, West Yorkshire, LS2 9AE, United Kingdom

Location

Unknown Facility

Liverpool, L20 5DQ, United Kingdom

Location

Unknown Facility

London, W12 0HS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27016644DERIVED

MeSH Terms

Interventions

etonogestrel

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

April 1, 2015

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations

FR(8)AU(5)SE(10)GB(6)NO(5)FI(9)