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Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

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ClinicalTrials.gov Identifier: NCT02556411
Recruitment Status : Unknown
Verified March 2016 by Stefano Angioni, University of Cagliari.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2015
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari

Tracking Information
First Submitted Date  ICMJE September 20, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date March 9, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 45 days of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02556411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 90 days of treatment ]
  • Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 180 days of treatment ]
  • Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 365 days of treatment ]
  • Quality of sexual life [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Official Title  ICMJE Not Provided
Brief Summary

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenomyosis
  • Chronic Pelvic Pain
Intervention  ICMJE
  • Drug: LNG-IUS 13,5 mg Levonorgestrel
    LNG-IUS
  • Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
    Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime
Study Arms  ICMJE
  • Active Comparator: LNG-IUS
    LNG-IUS 13,5 mg di Levonorgestrel
    Intervention: Drug: LNG-IUS 13,5 mg Levonorgestrel
  • Experimental: combined oral contraceptive plus LNG-IUS
    Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
    Interventions:
    • Drug: LNG-IUS 13,5 mg Levonorgestrel
    • Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women affected by adenomyosis with pelvic pain > 4;
  • Negative Pap Smear test

Exclusion Criteria:

  • Pregnancy or research of pregnancy
  • Refusal or inability to sign informed consent
  • Severe underlying comorbidities (hepatic, oncological)
  • Pelvic inflammatory disease
  • Other cervical or uterine pathologies
  • Deep venous thromboembolism
  • Hormonal therapy contraindications
  • Smoke
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556411
Other Study ID Numbers  ICMJE ADENOMYOSIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stefano Angioni, University of Cagliari
Study Sponsor  ICMJE University of Cagliari
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cagliari
Verification Date March 2016

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