LNGIUSAD: LNG-IUS for Treatment of Dysmenorrhea

• Sponsor: Omar Mamdouh Shaaban (Other)
• Overall Status: Completed
• CT.gov ID: NCT01601366
• Collaborator: (none)
• Enrollment: 62
• Arms: 2
• Actual Duration (Months): 36

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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 Names: 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 Names: Gynera

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Omar Mamdouh Shaaban

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Mamdouh Shaaban, Dr., Assiut University
• ClinicalTrials.gov Identifier: NCT01601366
• Other Study ID Numbers: LNG-IUS-dysmenorrhea; AUM001206
• First Posted: May 18, 2012
• Last Update Posted: Nov 22, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Omar Mamdouh Shaaban, Dr., Assiut University: Adenomyosis; Intrauterine levonorgestrel; Dysmenorrhea; Oral contraceptives; Uterus
• Additional relevant MeSH terms: Adenomyosis; Dysmenorrhea; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

No Results Posted as of Nov 22, 2017