Improve Quality of LifePhase 3NCT02943655
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
A Phase 3 study testing combined contraceptive pills (microcept), medroxyprogesterone acetate (progest) and mefenamic acid (ponstan forte) in people with Improve Quality of Life and Heavy Menstrual Bleeding, run by Assiut University at 1 site in Egypt.
Trial summary
Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Improve Quality of Life, Heavy Menstrual Bleeding
- What is being tested?
- combined contraceptive pills (microcept), medroxyprogesterone acetate (progest) and mefenamic acid (ponstan forte)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 10 Feb 2021
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.
Who cannot join
- Postmenopausal bleeding (over one year since the last menstrual period).
- Irregular menses or intermenstrual bleeding.
- Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
- Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g. non-progestogen-releasing intrauterine contraceptive device, oral contraceptives, other hormonal drug use or anticoagulant agent).
- Iron deficiency anemia.
- History of chronic diseases known to interfere with menstrual bleeding or prevent the use of any of the listed drugs e.g previous or current thromboembolic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.
- Conditions
- Improve Quality of Life, Heavy Menstrual Bleeding
- Being tested
- combined contraceptive pills (microcept), medroxyprogesterone acetate (progest), mefenamic acid (ponstan forte)
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined contraceptive pills (microcept)Drug
Also called microcept
oral combined contraceptive once daily
medroxyprogesterone acetate (progest)Drug
Also called progest
oral 5 mg medroxyprogesterone acetate daily
mefenamic acid (ponstan forte)Drug
Also called ponstan forte
oral 500 mg mefenamic acid three times per day
| Study group | Role | What they receive |
|---|---|---|
| combined oral contraceptives | Active comparator | oral second generation pills one tablet daily Receives: Drug: combined contraceptive pills (microcept) |
| medroxyprogesterone acetate | Active comparator | oral 5 mg daily Receives: Drug: medroxyprogesterone acetate (progest) |
| non-steroidal anti-inflammatory | Active comparator | oral 500 mg mefenamic acid three times per day Receives: Drug: mefenamic acid (ponstan forte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of menstrual blood loss
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 posted25 Oct 2016 (estimated)
- Study start1 Nov 2017
- Primary completion10 Oct 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Quality of LifeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943655
- Sponsor's protocol ID
- HVB
- Status last verified
- Jun 2021
- First submitted
- 21 Oct 2016
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
- ClinicalTrials.gov ID
- NCT02943655
- Acronym / sponsor ID
- HVB
- Conditions
- Improve Quality of Life, Heavy Menstrual Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 25 Oct 2016 (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.
Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined oral contraceptives | Active comparator | Drug: combined contraceptive pills (microcept)oral second generation pills one tablet daily |
| medroxyprogesterone acetate | Active comparator | Drug: medroxyprogesterone acetate (progest)oral 5 mg daily |
| non-steroidal anti-inflammatory | Active comparator | Drug: mefenamic acid (ponstan forte)oral 500 mg mefenamic acid three times per day |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.
Key exclusion criteria (6 listed)
- Postmenopausal bleeding (over one year since the last menstrual period).
- Irregular menses or intermenstrual bleeding.
- Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
- Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g. non-progestogen-releasing intrauterine contraceptive device, oral contraceptives, other hormonal drug use or anticoagulant agent).
- Iron deficiency anemia.
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 |
|---|---|---|
| combined contraceptive pills (microcept)Also: microceptoral combined contraceptive once daily | Drug | combined oral contraceptives |
| medroxyprogesterone acetate (progest)Also: progestoral 5 mg medroxyprogesterone acetate daily | Drug | medroxyprogesterone acetate |
| mefenamic acid (ponstan forte)Also: ponstan forteoral 500 mg mefenamic acid three times per day | Drug | non-steroidal anti-inflammatory |
Primary outcome
the amount of menstrual blood loss
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 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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 3 study testing combined contraceptive pills (microcept), medroxyprogesterone acetate (progest) and mefenamic acid (ponstan forte) in people with Improve Quality of Life and Heavy Menstrual Bleeding, run by Assiut University 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 1 inclusion and 6 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 4 Jun 2021. 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. 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?
the amount of menstrual blood loss (time frame: 3 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 4 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.