LNG-IUS for Treatment of Dysmenorrhea (LNGIUSAD)
Primary Purpose
Adenomyosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LNG-IUS
Combined oral contraceptives
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis focused on measuring Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LNG-IUS (Mirena)
Combined oral contraceptives
Arm Description
Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them
Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months
Outcomes
Primary Outcome Measures
Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.
Secondary Outcome Measures
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601366
Brief Title
LNG-IUS for Treatment of Dysmenorrhea
Acronym
LNGIUSAD
Official Title
Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omar Mamdouh Shaaban
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
Keywords
Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LNG-IUS (Mirena)
Arm Type
Experimental
Arm Description
Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them
Arm Title
Combined oral contraceptives
Arm Type
Active Comparator
Arm Description
Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months
Intervention Type
Device
Intervention Name(s)
LNG-IUS
Other Intervention Name(s)
Mirena
Intervention Description
The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them
Intervention Type
Drug
Intervention Name(s)
Combined oral contraceptives
Other Intervention Name(s)
Gynera
Intervention Description
Group II: will recite combined oral contraceptives for 6 months
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
LNG-IUS for Treatment of Dysmenorrhea
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