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Trial record 45 of 408 for:    LEVONORGESTREL

A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative). (COLIBRI)

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ClinicalTrials.gov Identifier: NCT02957292
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Number of menstrual bleeding days [ Time Frame: 90 days ]
    Daily recorded during 90 days treatment period
  • Amount of Menstrual bleeding [ Time Frame: 90 days ]
    Classified using a 5-item Likert-like scale from none to heavy, a pictorial blood loss assessment chart (PBAC), and ferritin and haemoglobin blood test determinations
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).
Official Title  ICMJE A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
Brief Summary

The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age.

Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea.

In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.

The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users.

This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: Levonorgestrel (13,5 mg) intrauterine device
  • Device: Cooper (380mm2) intrauterine device
Study Arms  ICMJE
  • Experimental: Levonorgestrel IUD
    13,5 mg Levonorgestrel intrauterine device
    Intervention: Drug: Levonorgestrel (13,5 mg) intrauterine device
  • Active Comparator: Copper IUD
    Copper (380mm2) intrauterine device
    Intervention: Device: Cooper (380mm2) intrauterine device
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
106
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subject.
  • Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
  • History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.

Exclusion Criteria:

  • Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
  • Contraindications to use 13,5 LNG-IUD.
  • Anemia.
  • Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
  • Known bleeding irregularities.
  • Pregnancy or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Josep Perelló, MD +34935537041 jperello@santpau.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957292
Other Study ID Numbers  ICMJE IIBSP-DIU-2015-85
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Bayer
Investigators  ICMJE Not Provided
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date November 2016

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