AdenomyosisPhase 2LNGIUSADNCT01601366
LNG-IUS for Treatment of Dysmenorrhea
A Phase 2 study testing LNG-IUS and Combined oral contraceptives in people with Adenomyosis, run by Omar Mamdouh Shaaban.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- What is being tested?
- LNG-IUS and Combined oral contraceptives
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Evidence of defective coagulation.
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Incidental adnexal abnormality on ultrasound.
- Contraindications to COCs.
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- Absolute contraindication of LNG-IUS insertion.
- Previous endometrial ablation or resection
- Uninvestigated postcoital bleeding
- Untreated abnormal cervical cytology
About this study
Official title: 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.
Read more
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
- Being tested
- LNG-IUS, Combined oral contraceptives
- Keywords
- Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus
- Medical subject headings
- Adenomyosis, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUSDevice
Also called Mirena
The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them
Combined oral contraceptivesDrug
Also called Gynera
Group II: will recite combined oral contraceptives for 6 months
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS (Mirena) | Experimental | Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them Receives: 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 Receives: Drug: Combined oral contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.
Measured: 6 month
Secondary outcomes (1)
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Mamdouh Shaaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601366
- Sponsor's protocol ID
- LNG-IUS-dysmenorrhea
- Other IDs
- AUM001206
- Acronym
- LNGIUSAD
- Status last verified
- Nov 2017
- First submitted
- 15 May 2012
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01601366
- Acronym / sponsor ID
- LNGIUSAD / LNG-IUS-dysmenorrhea
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Omar Mamdouh ShaabanUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-IUS (Mirena) | Experimental | Device: LNG-IUSGroup I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them |
| Combined oral contraceptives | Active comparator | Drug: Combined oral contraceptivesGroup II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnancy
- Evidence of defective coagulation.
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Incidental adnexal abnormality on ultrasound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNG-IUSAlso: MirenaThe study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them | Device | LNG-IUS (Mirena) |
| Combined oral contraceptivesAlso: GyneraGroup II: will recite combined oral contraceptives for 6 months | Drug | Combined oral contraceptives |
Primary outcome
Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.
Time frame: 6 month
1 secondary outcome
Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LNG-IUS and Combined oral contraceptives in people with Adenomyosis, run by Omar Mamdouh Shaaban.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.