EndometriosisPhase 1/2NCT01791413
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
A Phase 1/2 study testing depot medroxyprogesterone acetate in people with Endometriosis, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- depot medroxyprogesterone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women 18-40 years old
- A diagnosis of endometrioma with diameter of at least 3 cm.
- Candidates for laparoscopic cystectomy
Who cannot join
- Patients' refusal to participate
- Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
- Use of estrogen-suppressive drugs in the preceding 3 months, such as:
- Oral contraceptives, GnRH analogues, Progestins, Danazol
- Pathology report present no endometriosis
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Obstetrics and Gynecology
Ratchathewi, Bangkok, 10400
About this study
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.
- Conditions
- Endometriosis
- Being tested
- depot medroxyprogesterone acetate
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depot medroxyprogesterone acetateDrug
DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| depot medroxyprogesterone acetate | Active comparator | Not described Receives: Drug: depot medroxyprogesterone acetate |
| No depot medroxyprogesterone acetate | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
Measured: Within the first 2 weeks and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Mahidol 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weena Krutsawad, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791413
- Sponsor's protocol ID
- 02-55-13
- Status last verified
- Aug 2013
- First submitted
- 10 Feb 2013
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
- ClinicalTrials.gov ID
- NCT01791413
- Acronym / sponsor ID
- 02-55-13
- Conditions
- Endometriosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 23 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depot medroxyprogesterone acetate | Active comparator | Drug: depot medroxyprogesterone acetate |
| No depot medroxyprogesterone acetate | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women 18-40 years old
- A diagnosis of endometrioma with diameter of at least 3 cm.
- Candidates for laparoscopic cystectomy
Key exclusion criteria (5 listed)
- Patients' refusal to participate
- Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
- Use of estrogen-suppressive drugs in the preceding 3 months, such as:
- Oral contraceptives, GnRH analogues, Progestins, Danazol
- Pathology report present no endometriosis
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 |
|---|---|---|
| depot medroxyprogesterone acetateDMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks) | Drug | depot medroxyprogesterone acetate |
Primary outcome
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
Time frame: Within the first 2 weeks and 3 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing depot medroxyprogesterone acetate in people with Endometriosis, run by Mahidol University at 1 site in Thailand.
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 3 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: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation (time frame: Within the first 2 weeks and 3 months after surgery). 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 9 Sep 2013.