LNG-IUS for Treatment of Dysmenorrhea (LNGIUSAD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Assiut University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, Assiut University
ClinicalTrials.gov Identifier:
NCT01601366
First received: May 15, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Adenomyosis
Device: LNG-IUS
Drug: Combined oral contraceptives
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Omar Mamdouh Shaaban, Dr., Assiut University
ClinicalTrials.gov Identifier: NCT01601366     History of Changes
Other Study ID Numbers: LNG-IUS-dysmenorrhea, AUM001206
Study First Received: May 15, 2012
Last Updated: May 16, 2012
Health Authority: Egypt:Medical School Ethical Review Board

Keywords provided by Assiut University:
Adenomyosis
Intrauterine levonorgestrel
Dysmenorrhea
Oral contraceptives
Uterus

Additional relevant MeSH terms:
Adenomyosis
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 22, 2014