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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

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


Condition or disease Intervention/treatment Phase
Adenomyosis Chronic Pelvic Pain Drug: LNG-IUS 13,5 mg Levonorgestrel Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Active Comparator: LNG-IUS
LNG-IUS 13,5 mg di Levonorgestrel
Drug: LNG-IUS 13,5 mg Levonorgestrel
LNG-IUS

Experimental: combined oral contraceptive plus LNG-IUS
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
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




Primary Outcome Measures :
  1. Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 45 days of treatment ]

Secondary Outcome Measures :
  1. Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 90 days of treatment ]
  2. Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 180 days of treatment ]
  3. Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 365 days of treatment ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02556411     History of Changes
Other Study ID Numbers: ADENOMYOSIS
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Pelvic Pain
Adenomyosis
Pain
Neurologic Manifestations
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female
Contraceptives, Oral
Levonorgestrel
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists