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LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel IUD (LCS, BAY86-5028) (Drug); Yasmin (EE30/DRSP, BAY86-5131) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study. Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.

Clinical Details

Official title: Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)

Secondary outcome:

Overall Satisfaction Rating by the 5-point Likert Item at 6 Months

Overall Satisfaction Rating by the 5-point Likert Item at 12 Months

Overall Satisfaction Rating by the 5-point Likert Item at 18 Months

Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)

Overall Satisfaction Rate at 6 Months (LOCF)

Overall Satisfaction Rate at 12 Months (LOCF)

User Satisfaction - Acceptability of the Administration of Study Treatment

User Satisfaction - Choices Upon Completion of the Study

User Satisfaction - Amount of Menstrual Bleeding

User Satisfaction - Satisfaction With Menstrual Bleeding Pattern

User Satisfaction - Frequency of Experiencing Unexpected Bleeding

User Satisfaction - Satisfaction With Menstrual Bleeding Absence

User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment

User Satisfaction - Rating of Usual Menstrual Pain Intensity

EVAPIL-R Scores at Screening - Composite Score

EVAPIL-R Scores at Screening - Bother Score

EVAPIL-R Scores at 6 Months

EVAPIL-R Scores at 12 Months - Composite Score

EVAPIL-R Scores at 12 Months - Bother Score

EVAPIL-R Scores at 18 Months/EOS

Drop-out Rate

Pearl Index (PI)

Compliance Rate for Yasmin Pill Intake

Eligibility

Minimum age: 18 Years. Maximum age: 29 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Subject has signed and dated the Informed Consent Form (ICF).

- The subject is generally healthy, requesting contraception, and is between 18 and 29

years of age (inclusive) at Screening.

- In the opinion of the investigator, the subject is

- in good health;

- without uterine conditions that would preempt insertion of LCS12;

- without conditions/history that would contraindicate the use of oral

contraceptives.

- Subject has normal or clinically insignificant cervical smear (ie, one that does not

require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.

- As determined by subject's history, subject has regular (ie, endogenous cyclicity

without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).

- 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 since vaginal or Cesarean delivery

or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.

- Infected abortion or postpartum endometritis within 3 months prior to the Screening

Visit (Visit 1)

- Chronic, daily use of drugs that may increase serum potassium levels, such as

nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.

- Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding

- Any genital infection (until successfully treated)

- Abnormal cervical smear result (see inclusion criteria)

- Acute, current or history of recurrent pelvic inflammatory disease

- Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg,

by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.

Locations and Contacts

Graz 8010, Austria

Klagenfurt 9020, Austria

Tulln 3430, Austria

Wien 1070, Austria

Wien 1200, Austria

Zeltweg 8740, Austria

Antwerpen 2018, Belgium

Bruxelles-brussel 1070, Belgium

Ekeren 2180, Belgium

Gent 9000, Belgium

Leuven 3000, Belgium

Hamburg 22587, Germany

Hamburg 21073, Germany

Hamburg 22159, Germany

Barnaul 656038, Russian Federation

Irkutsk 664003, Russian Federation

Ivanovo 153045, Russian Federation

Novosibirsk 630089, Russian Federation

St. Petersburg 199034, Russian Federation

Tucson, Arizona 85712, United States

Ettlingen, Baden-WĂĽrttemberg 76275, Germany

La Mesa, California 91942, United States

San Diego, California 92103, United States

San Diego, California 92108, United States

Boynton Beach, Florida 33472-2952, United States

Boston, Massachusetts 02118, United States

Lincoln, Nebraska 68510, United States

Hannover, Niedersachsen 30459, Germany

St. Pölten, Niederösterreich 3100, Austria

Wiener Neustadt, Niederösterreich 2700, Austria

Geseke, Nordrhein-Westfalen 59590, Germany

Köln, Nordrhein-Westfalen 50931, Germany

Columbus, Ohio 43213, United States

Portland, Oregon 97239-3011, United States

Philadelphia, Pennsylvania 19114, United States

Dippoldiswalde, Sachsen 01744, Germany

Dresden, Sachsen 01169, Germany

Leipzig, Sachsen 04299, Germany

Leipzig, Sachsen 04207, Germany

Bernburg, Sachsen-Anhalt 06406, Germany

Blankenburg, Sachsen-Anhalt 38889, Germany

Jessen, Sachsen-Anhalt 06917, Germany

Magdeburg, Sachsen-Anhalt 39104, Germany

Voitsberg, Steiermark 8570, Austria

Corpus Christi, Texas 78414, United States

Bregenz, Vorarlberg 6900, Austria

Seattle, Washington 98105, United States

Additional Information

Click here and search for drug information provided by the FDA.

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Starting date: January 2011
Last updated: June 29, 2015

Page last updated: August 23, 2015

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