EndometriosisPhase 4NCT01056042
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
A Phase 4 study testing intramuscular depot medroxyprogesterone acetate and ethinyl estradiol 30 micrograms, gestodene 75 micrograms in people with Endometriosis, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- intramuscular depot medroxyprogesterone acetate and ethinyl estradiol 30 micrograms, gestodene 75 micrograms
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to Oct 2011
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.
Who cannot join
- Medical therapies for endometriosis other than NSAID within previous 6 months
- Contraindication to the drugs
- Wish to conceive
- Request for extirpative surgery
- Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.
- Conditions
- Endometriosis
- Being tested
- intramuscular depot medroxyprogesterone acetate, ethinyl estradiol 30 micrograms, gestodene 75 micrograms
- Keywords
- pelvic pain, postoperative, medical therapy
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular depot medroxyprogesterone acetateDrug
Also called Depo Provera
150 mg, Intramuscular, every 3 months
ethinyl estradiol 30 micrograms, gestodene 75 microgramsDrug
Also called Gynera
one tablet orally, everyday
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intramuscular depot medroxyprogesterone acetate Receives: Drug: intramuscular depot medroxyprogesterone acetate |
| B | Active comparator | ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms Receives: Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction with the treatment
Measured: 1 year and 6 months
Secondary outcomes (1)
pain reduction and adverse side effects
Measured: 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJun 2007
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sopon Cheewadhanaraks, Prince of Songkla University
- Investigators
- Sopon Cheewadhanaraks, M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056042
- Sponsor's protocol ID
- EC 50/370-029
- Status last verified
- Oct 2014
- First submitted
- 25 Jan 2010
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vercellini P, Frontino G, De Giorgi O, Pietropaolo G, Pasin R, Crosignani PG. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003 Sep;80(3):560-3. doi: 10.1016/s0015-0282(03)00794-5.
PubMed 12969698
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
- ClinicalTrials.gov ID
- NCT01056042
- Acronym / sponsor ID
- EC 50/370-029
- Conditions
- Endometriosis
- Keywords
- pelvic pain, postoperative, medical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jan 2010 (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.
Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: intramuscular depot medroxyprogesterone acetateIntramuscular depot medroxyprogesterone acetate |
| B | Active comparator | Drug: ethinyl estradiol 30 micrograms, gestodene 75 microgramsethinyl estradiol 30 micrograms combined with gestodene 75 micrograms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.
Key exclusion criteria (5 listed)
- Medical therapies for endometriosis other than NSAID within previous 6 months
- Contraindication to the drugs
- Wish to conceive
- Request for extirpative surgery
- Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
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 |
|---|---|---|
| intramuscular depot medroxyprogesterone acetateAlso: Depo Provera150 mg, Intramuscular, every 3 months | Drug | A |
| ethinyl estradiol 30 micrograms, gestodene 75 microgramsAlso: Gyneraone tablet orally, everyday | Drug | B |
Primary outcome
Patients' satisfaction with the treatment
Time frame: 1 year and 6 months
1 secondary outcome
pain reduction and adverse side effects
Time frame: 1 year and 6 months
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 29 Oct 2014.
- Background: PubMed 12969698Vercellini P, Frontino G, De Giorgi O, Pietropaolo G, Pasin R, Crosignani PG. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003 Sep;80(3):560-3. doi: 10.1016/s0015-0282(03)00794-5.
- Faculty of Medicine, Prince of Songkla UniversityLink provided by the sponsor.
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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.
Sopon Cheewadhanaraks, M.D. principal investigator
Faculty of Medicine, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intramuscular depot medroxyprogesterone acetate and ethinyl estradiol 30 micrograms, gestodene 75 micrograms in people with Endometriosis, run by Prince of Songkla 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 1 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 29 Oct 2014. 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 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?
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?
Patients' satisfaction with the treatment (time frame: 1 year and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056042, which also lists 1 linked publication.
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 29 Oct 2014.