LNG-IUS for Treatment of Dysmenorrhea

NCT01601366 | Completed Phase 2 DMC

• 2 other identifiers: LNG-IUS-dysmenorrheaAUM001206
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.

  6 month

Secondary Outcomes (1)

• Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months

  6 month

Study Arms (2)

LNG-IUS (Mirena)

EXPERIMENTAL

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

Device: LNG-IUS

Combined oral contraceptives

ACTIVE COMPARATOR

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

Drug: Combined oral contraceptives

Interventions

LNG-IUS DEVICE

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

Also known as: Mirena

LNG-IUS (Mirena)

Combined oral contraceptives DRUG

Group II: will recite combined oral contraceptives for 6 months

Also known as: Gynera

Combined oral contraceptives

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis.
• Planning for birth spacing for at least 2 years.
• Patient aged between 20-45 years old.
• Ultrasonographic and Doppler examination suggestive of adenomyosis.
• Living in a nearby area to make follow-up reasonably possible.

You may not qualify if:

• Pregnancy
• Evidence of defective coagulation.
• History or evidence of malignancy.
• Hyperplasia in the endometrial biopsy.
• Incidental adnexal abnormality on ultrasound.
• Contraindications to COCs.
• Absolute contraindication of LNG-IUS insertion.
• Previous endometrial ablation or resection
• Uninvestigated postcoital bleeding
• Untreated abnormal cervical cytology

Sponsors & Collaborators

• Omar Mamdouh Shaaban: lead

MeSH Terms

Conditions

Adenomyosis; Dysmenorrhea

Interventions

Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2015
• Last Updated: November 22, 2017

Record last verified: 2017-11