Clinical trial NCT01254292: LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 567
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
timeFrame: At 18 months
Secondary outcomes:
measure: Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
timeFrame: At 6 months
measure: Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
timeFrame: At 12 months
measure: Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
timeFrame: At 18 months
measure: Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
timeFrame: At 18 months/EOS
measure: Overall Satisfaction Rate at 6 Months (LOCF)
timeFrame: At 6 months
measure: Overall Satisfaction Rate at 12 Months (LOCF)
timeFrame: At 12 months
measure: User Satisfaction - Acceptability of the Administration of Study Treatment
timeFrame: At 18 months/EOS
measure: User Satisfaction - Choices Upon Completion of the Study
timeFrame: At 18 months/EOS
measure: User Satisfaction - Amount of Menstrual Bleeding
timeFrame: At 18 months/EOS
measure: User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
timeFrame: At 18 months/EOS
measure: User Satisfaction - Frequency of Experiencing Unexpected Bleeding
timeFrame: At 18 months/EOS
measure: User Satisfaction - Satisfaction With Menstrual Bleeding Absence
timeFrame: At 18 months/EOS
measure: User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment
timeFrame: At 18 months/EOS
measure: User Satisfaction - Rating of Usual Menstrual Pain Intensity
timeFrame: At 18 months/EOS
measure: EVAPIL-R Scores at Screening - Composite Score
timeFrame: At screening
measure: EVAPIL-R Scores at Screening - Bother Score
timeFrame: At screening
measure: EVAPIL-R Scores at 6 Months
timeFrame: At 6 months
measure: EVAPIL-R Scores at 12 Months - Bother Score
timeFrame: At 12 months
measure: EVAPIL-R Scores at 12 Months - Composite Score
timeFrame: At 12 months
measure: EVAPIL-R Scores at 18 Months/EOS
timeFrame: At 18 months/EOS
measure: Cumulative Drop-out Rate
timeFrame: Up to 6, 12, 18, 24 and 36 months
measure: Pearl Index (PI)
timeFrame: Up to 18, 24, 36 months
measure: Compliance Rate for Yasmin Pill Intake
timeFrame: Up to 18 months
measure: User Satisfaction - Acceptability of the Administration of Study Treatment
timeFrame: At 6 months
measure: User Satisfaction - Acceptability of the Administration of Study Treatment
timeFrame: At 12 months
Other outcomes:
measure: Cumulative Number of Participants With Partial or Total Expulsion
timeFrame: Up to 18, 24, 36 months
measure: Investigator's Evaluation of Successful IUS Insertion Procedure
timeFrame: Up to 18 months
measure: Participants' Evaluation of Pain During Successful IUS Insertion Procedure
timeFrame: Up to 18 months
measure: Investigator's Evaluation of IUS Removal Procedure
timeFrame: Up to 36 months
measure: Participants' Evaluation of Pain During IUS Removal Procedure
timeFrame: Up to 36 months
Locations:
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Tucson
country: United States
state: Arizona
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: La Mesa
country: United States
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Seattle
country: United States
state: Washington
city: St. Pölten
country: Austria
facility: Ordination Dr. Schmidl-Amann
state: Niederösterreich
city: St. Pölten
country: Austria
state: Niederösterreich
city: Wiener Neustadt
country: Austria
facility: Dr. Max Stiglbauer
state: Niederösterreich
city: Wiener Neustadt
country: Austria
state: Niederösterreich
city: Voitsberg
country: Austria
facility: Ordination Dr. Trost
state: Steiermark
city: Voitsberg
country: Austria
state: Steiermark
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
state: Vorarlberg
city: Bregenz
country: Austria
state: Vorarlberg
city: Graz
country: Austria
facility: Praxis Dr. Hannes Kahr
city: Graz
country: Austria
city: Klagenfurt
country: Austria
facility: Dr. Bernhard Svejda
city: Klagenfurt
country: Austria
city: Tulln
country: Austria
facility: Ordination Dr. Sator
city: Tulln
country: Austria
city: Wien
country: Austria
facility: Dr. Brigitte Wiesenthal
city: Wien
country: Austria
city: Wien
country: Austria
facility: Dr. Wolfgang Bartl
city: Wien
country: Austria
city: Zeltweg
country: Austria
facility: Dr. Walter Paulik
city: Zeltweg
country: Austria
city: Antwerpen
country: Belgium
facility: Dr. Philip Loquet
city: Antwerpen
country: Belgium
city: Bruxelles-brussel
country: Belgium
facility: Hôpital Erasme/Erasmus Ziekenhuis
city: Bruxelles-brussel
country: Belgium
city: Ekeren
country: Belgium
facility: Gynaecologen Noord Antwerpen
city: Ekeren
country: Belgium
city: Gent
country: Belgium
facility: UZ Gent
city: Gent
country: Belgium
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Leuven
country: Belgium
city: Ettlingen
country: Germany
facility: Praxis Hr. Dr. A. Soder
state: Baden-Württemberg
city: Ettlingen
country: Germany
state: Baden-Württemberg
city: Hannover
country: Germany
facility: Praxis Hr. Dr. K. Greven
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Geseke
country: Germany
facility: Praxis Hr. Dr. E. Goeckeler-Leopold
state: Nordrhein-Westfalen
city: Geseke
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Köln Weyertal gGmbH
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
facility: Praxis f. Gynäkologie und Geburtshilfe
state: Sachsen-Anhalt
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
facility: Frauenarztpraxis Dr. Wetzel
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
facility: Praxis Hr. H. Thelen
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Praxis Fr. Dr. A. Braune
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dippoldiswalde
country: Germany
facility: Frauenarztpraxis Dr. Robert Hantschel
state: Sachsen
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Dresden
country: Germany
facility: Praxis Hr. Dr. U. Kopprasch
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
facility: Frauenarztpraxis Dr. Bernd Pittner
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
facility: Praxis Fr. C. Burgkhardt
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
facility: Praxis Hr. Dr. D. Rautenberg
city: Hamburg
country: Germany
city: Hamburg
country: Germany
facility: Praxis Hr. Dr. K. Peters
city: Hamburg
country: Germany
city: Hamburg
country: Germany
facility: Praxis Hr. Dr. K. Buehling
city: Hamburg
country: Germany
city: Barnaul
country: Russian Federation
facility: Altai State Medical University
city: Barnaul
country: Russian Federation
city: Irkutsk
country: Russian Federation
facility: Scientific Center of family health & human reprod. problems
city: Irkutsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
facility: Instit. of Motherhood & Childhood care n.a. Gorodkov
city: Ivanovo
country: Russian Federation
city: Novosibirsk
country: Russian Federation
facility: City Perinatal Center
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
facility: Institute of Obsteric & Gyn.
city: St. Petersburg
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: