LNG-IUS for Treatment of Dysmenorrhea (LNGIUSAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Adenomyosis
• Intervention / Treatment: Device: LNG-IUS; Drug: Combined oral contraceptives

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months	6 month

Collaborators and Investigators

• Sponsor: Omar Mamdouh Shaaban

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Adenomyosis; Oral contraceptives; Uterus; Intrauterine levonorgestrel
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Adenomyosis; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
• Other Study ID Numbers: LNG-IUS-dysmenorrhea; AUM001206