Uterine HemorrhagePhase 3DOX-DMPANCT01254799
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
A Phase 3 study testing Doxycycline in people with Uterine Hemorrhage, run by Omar Mamdouh Shaaban at 1 site in Egypt.
Trial summary
This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only". Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Uterine Hemorrhage
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2008to Jan 2011
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women under DMPA contraception for at least one month.
- Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients.
- Women's ability to keep an accurate menstrual diary for the study.
Who cannot join
- Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
- Patients with already diagnosed local gynecological abnormality.
- Women receiving treatment for bleeding within the last one month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".
- Conditions
- Uterine Hemorrhage
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
100 mg Doxycycline capsules twice daily for 5 days
PlaceboDrug
Placebo capsules twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Women in this arm will receive identical Placebo capsules twice daily for 5 days Receives: Drug: Placebo |
| Doxycycline | Active comparator | Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoppage of bleeding within 7 days
Measured: 7 days from starting of tretment
Secondary outcomes (6)
Number of days needed to stop a current attack of bleeding
Measured: 1 month
Next bleeding free interval
Measured: 3 month
Uterine bleeding patterns in the next 3 months after treatment
Measured: 3 months
Women satisfaction with the treatment she received
Measured: 3 months
Side effects encountered during treatment
Measured: 5 days
Discontinuation of the DMPA and its reason
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionJan 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 Uterine HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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
- Investigators
- Hany Abdel-Aleem, MD, Principal investigator, Assiut UniversityOmar M Shaaban, MD, Study director, Assiut UniversityMahmoud Abdel=Aleem, MD, Study chair, Assiut UniversityGehian N Fetih, PH.D, Study chair, Faculty of Pharmacy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254799
- Sponsor's protocol ID
- DOX-DMPA
- Acronym
- DOX-DMPA
- Status last verified
- Nov 2011
- First submitted
- 6 Dec 2010
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Fetih GN. Doxycycline in the treatment of bleeding with DMPA: a double-blinded randomized controlled trial. Contraception. 2012 Sep;86(3):224-30. doi: 10.1016/j.contraception.2012.01.003. Epub 2012 Feb 9.
PubMed 22325113
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01254799
- Acronym / sponsor ID
- DOX-DMPA / DOX-DMPA
- Conditions
- Uterine Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Omar Mamdouh ShaabanUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Dec 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.
This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWomen in this arm will receive identical Placebo capsules twice daily for 5 days |
| Doxycycline | Active comparator | Drug: DoxycyclineWomen in this arm will receive 100 mg doxycycline capsules twice daily for 5 days |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women under DMPA contraception for at least one month.
- Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients.
- Women's ability to keep an accurate menstrual diary for the study.
Key exclusion criteria (3 listed)
- Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
- Patients with already diagnosed local gynecological abnormality.
- Women receiving treatment for bleeding within the last one month.
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 |
|---|---|---|
| Doxycycline100 mg Doxycycline capsules twice daily for 5 days | Drug | Doxycycline |
| PlaceboPlacebo capsules twice daily for 5 days | Drug | Placebo |
Primary outcome
Stoppage of bleeding within 7 days
Time frame: 7 days from starting of tretment
6 secondary outcomes
Number of days needed to stop a current attack of bleeding
Time frame: 1 month
Next bleeding free interval
Time frame: 3 month
Uterine bleeding patterns in the next 3 months after treatment
Time frame: 3 months
Women satisfaction with the treatment she received
Time frame: 3 months
Side effects encountered during treatment
Time frame: 5 days
Discontinuation of the DMPA and its reason
Time frame: 3 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 28 Nov 2011.
- Derived from this study: PubMed 22325113Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Fetih GN. Doxycycline in the treatment of bleeding with DMPA: a double-blinded randomized controlled trial. Contraception. 2012 Sep;86(3):224-30. doi: 10.1016/j.contraception.2012.01.003. Epub 2012 Feb 9.
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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.
Hany Abdel-Aleem, MD principal investigator
Assiut University
Omar M Shaaban, MD study director
Assiut University
Mahmoud Abdel=Aleem, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline in people with Uterine Hemorrhage, run by Omar Mamdouh Shaaban at 1 site in Egypt.
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 3 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 28 Nov 2011. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Stoppage of bleeding within 7 days (time frame: 7 days from starting of tretment). 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 NCT01254799, 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 28 Nov 2011.