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Trial record 27 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

LCS16 vs. COC User Satisfaction and Tolerability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074045
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 8, 2017
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE March 13, 2017
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
Overall satisfaction rate [ Time Frame: 12 months ]
5-point Likert item
  1. Very satisfied
  2. Satisfied
  3. Neither satisfied nor dissatisfied
  4. Dissatisfied
  5. Very dissatisfied
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03074045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • Number of adverse events [ Time Frame: Up to 5 years ]
    at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
  • Discontinuation rates [ Time Frame: Up to 5 years ]
    at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
  • Bleeding pattern [ Time Frame: Up to 12 months ]
    Only during the comparative part of the study
  • User satisfaction and bleeding questionnaire [ Time Frame: Up to 12 months ]
    At 6 and 12 months after the start of study treatment (or at early termination for those subjects discontinuing the study before completion of the 12 months) for all subjects during the comparative part of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • Number of adverse events [ Time Frame: Up to 5 years ]
    at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
  • Discontinuation rates [ Time Frame: Up to 5 years ]
    at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
  • Bleeding pattern [ Time Frame: Up to 12 months ]
    Only during the comparative part of the study
  • User satisfaction and bleeding questionnaire [ Time Frame: Up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LCS16 vs. COC User Satisfaction and Tolerability Study
Official Title  ICMJE Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)
Brief Summary To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: Levonorgestrel (Kyleena, BAY86-5028)
    Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years
  • Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
    COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months
Study Arms  ICMJE
  • Experimental: Test
    LCS16 (Low-dose LNG IUS)
    Intervention: Drug: Levonorgestrel (Kyleena, BAY86-5028)
  • Active Comparator: Reference
    COC (Yarina)
    Intervention: Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
123
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2017)
150
Estimated Study Completion Date  ICMJE September 1, 2022
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject has signed and dated the Informed Consent Form (ICF).
  • The subject is healthy when requesting contraception.
  • The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.
  • The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months).
  • The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.
  • The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

  • Pregnancy or current lactation (less than 6 weeks postpartum or since abortion before the Screening Visit)
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.
  • Chronic, daily use of drugs that may increase serum potassium levels.
  • Undiagnosed abnormal genital bleeding.
  • Acute cervicitis or vaginitis (until successfully treated).
  • Lower urinary tract infection (until successfully treated).
  • Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.
  • Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
  • Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.
  • History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03074045
Other Study ID Numbers  ICMJE 17878
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP