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LNG-IUS for Treatment of Dysmenorrhea (LNGIUSAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601366
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, Assiut University

Brief Summary:

Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the myometrium are associated with surrounding myometrial hypertrophy. The finding classically associated with adenomyosis is excessive uterine bleeding accompanied by worsening dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose adenomyosis. Different US features of adenomyosis have been reported, including uterine enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the anterior or posterior myometrial wall, lack of contour abnormality or mass effect, heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of varying sizes, and increased echotexture of the myometrium.

Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis and can aid clinicians in planning the most appropriate therapeutic strategy. The differential diagnosis using power Doppler sonography is based on vascular characteristics. Adenomyosis is characterized by a preserved vascular texture supply that results in dilated spiral arteries running perpendicular toward the myometrium into the endometrial surface. Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and facilitate appropriate therapeutic intervention.

The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe for contraception since 1990. Because of the suppressive effect of levonorgestrel on the endometrium, Mirena has also been proven to be effective for the management of menorrhagia and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the treatment of adenomyosis in Taiwan.

The current study is designed to evaluate the best treatment modality for treatment of adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler indices.

Condition or disease Intervention/treatment Phase
Adenomyosis Device: LNG-IUS Drug: Combined oral contraceptives Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial
Actual Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: LNG-IUS (Mirena)
Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them
Device: LNG-IUS
The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them
Other Name: Mirena

Active Comparator: Combined oral contraceptives
Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months
Drug: Combined oral contraceptives
Group II: will recite combined oral contraceptives for 6 months
Other Name: Gynera

Primary Outcome Measures :
  1. Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months [ Time Frame: 6 month ]

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis.
  2. Planning for birth spacing for at least 2 years.
  3. Patient aged between 20-45 years old.
  4. Ultrasonographic and Doppler examination suggestive of adenomyosis.
  5. Living in a nearby area to make follow-up reasonably possible.

Exclusion Criteria:

  1. Pregnancy
  2. Evidence of defective coagulation.
  3. History or evidence of malignancy.
  4. Hyperplasia in the endometrial biopsy.
  5. Incidental adnexal abnormality on ultrasound.
  6. Contraindications to COCs.
  7. Absolute contraindication of LNG-IUS insertion.
  8. Previous endometrial ablation or resection
  9. Uninvestigated postcoital bleeding
  10. Untreated abnormal cervical cytology

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Responsible Party: Omar Mamdouh Shaaban, Dr., Assiut University Identifier: NCT01601366     History of Changes
Other Study ID Numbers: LNG-IUS-dysmenorrhea
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Omar Mamdouh Shaaban, Assiut University:
Intrauterine levonorgestrel
Oral contraceptives

Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic