AdenomyosisPhase 4NCT03654144
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
A Phase 4 study testing Dienogest and Combined Oral Contraceptive in people with Adenomyosis, run by Assiut University.
Trial summary
Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Dienogest and Combined Oral Contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Mar 2020
- Phase
- Phase 4
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic adenomyosis
- irregular menstrual bleeding and dysmenorrhea .
Who cannot join
- asymptomatic patients -
- non-lactating patient
- not desire for pregnancy
- no hormonal treatment more than 6 month even contraception e.g IUD
- no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
About this study
Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium
- Conditions
- Adenomyosis
- Being tested
- Dienogest, Combined Oral Contraceptive
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
oral tablets
Combined Oral ContraceptiveDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | women will receive dienogest Receives: Drug: Dienogest |
| control group | Active comparator | women used combined oral contraceptive pills Receives: Drug: Combined Oral Contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean pain score after receiving treatment
assessment by visual analog scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startNov 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa mohamed hussin yousef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654144
- Sponsor's protocol ID
- DINADEN
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
- ClinicalTrials.gov ID
- NCT03654144
- Acronym / sponsor ID
- DINADEN
- Conditions
- Adenomyosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- 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 was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Dienogestwomen will receive dienogest |
| control group | Active comparator | Drug: Combined Oral Contraceptivewomen used combined oral contraceptive pills |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic adenomyosis
- irregular menstrual bleeding and dysmenorrhea .
Key exclusion criteria (5 listed)
- asymptomatic patients -
- non-lactating patient
- not desire for pregnancy
- no hormonal treatment more than 6 month even contraception e.g IUD
- no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
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 |
|---|---|---|
| Dienogestoral tablets | Drug | Study group |
| Combined Oral Contraceptiveoral tablets | Drug | control group |
Primary outcome
The mean pain score after receiving treatment
Time frame: 6 months
assessment by visual analog scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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 4 study testing Dienogest and Combined Oral Contraceptive in people with Adenomyosis, run by Assiut University.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The mean pain score after receiving treatment (time frame: 6 months). 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 31 Aug 2018.