LNG-IUS for Treatment of Dysmenorrhea

NCT ID: NCT01601366

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Adenomyosis

Keywords

Adenomyosis; Intrauterine levonorgestrel; Dysmenorrhea; Oral contraceptives; Uterus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LNG-IUS (Mirena)

Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them

Group Type: EXPERIMENTAL

LNG-IUS

Intervention Type: DEVICE

The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them

Combined oral contraceptives

Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months

Group Type: ACTIVE_COMPARATOR

Combined oral contraceptives

Intervention Type: DRUG

Group II: will recite combined oral contraceptives for 6 months

Interventions

LNG-IUS

The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them

Intervention Type: DEVICE

Combined oral contraceptives

Group II: will recite combined oral contraceptives for 6 months

Intervention Type: DRUG

Other Intervention Names

Mirena; Gynera

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Omar Mamdouh Shaaban

OTHER

Sponsor Role: lead

Responsible Party

Omar Mamdouh Shaaban

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

AUM001206

Identifier Type: -

Identifier Source: secondary_id

LNG-IUS-dysmenorrhea

Identifier Type: -

Identifier Source: org_study_id