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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01397097
First received: July 18, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: LNG-IUS (BAY 86-5028)
Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Discontinuation rate by treatment group [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discontinuation rates by treatment group [ Time Frame: at 6 months and by reason at 6 and 12 months ] [ Designated as safety issue: No ]
  • Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Pregnancy rate, as determined by Pearl index [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment: 766
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: LNG-IUS (BAY 86-5028)
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
Active Comparator: Arm 2 Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397097

  Show 43 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01397097     History of Changes
Other Study ID Numbers: 13363, 2010-023911-32
Study First Received: July 18, 2011
Last Updated: September 4, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
3-keto-desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014