Overview

This trial is active, not recruiting.

Condition adenomyosis
Treatments lng-ius, combined oral contraceptives
Phase phase 2
Sponsor Omar Mamdouh Shaaban
Start date April 2012
End date April 2013
Trial size 62 participants
Trial identifier NCT01601366, AUM001206, LNG-IUS-dysmenorrhea

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them
lng-ius Mirena
The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them
(Active Comparator)
Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months
combined oral contraceptives Gynera
Group II: will recite combined oral contraceptives for 6 months

Primary Outcomes

Measure
Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.
time frame: 6 month

Secondary Outcomes

Measure
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
time frame: 6 month

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

Official title Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Assiut University.