LNG-IUS for Treatment of Dysmenorrhea

Adenomyosis Clinical Trial

— LNGIUSAD  

Official title:

Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601366
• Other study ID #: LNG-IUS-dysmenorrhea
• Secondary ID: AUM001206
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2012
• Last updated: November 20, 2017
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Dysmenorrhea

Intervention

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

Drug:
• Combined oral contraceptives
Group II: will recite combined oral contraceptives for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Omar Mamdouh Shaaban

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.		6 month
Secondary	Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months		6 month