Polycystic Ovary SyndromePhase 3NCT01051024
Diamel in the Treatment of Polycystic Ovary Syndrome
A Phase 3 study testing Diamel in people with Polycystic Ovary Syndrome, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Diamel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCuba
- Study dates
- Nov 2009to Apr 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Two of the following criteria:
- Oligo or Anovulation
- Polycystic Ovary diagnosed by ultrasound technique
- Clinical signs of Hyperandrogenism
- Signed informed consent
Who cannot join
- Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
- Patients under other experimental treatment
- Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
- Treatment with vitamins within 7 days before treatment
- Treatment with dietary supplements within 60 days before treatment
- Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, La Habana, 10400
About this study
Official title: Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Diamel, Placebo
- Keywords
- Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamelDietary supplement
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
PlaceboDietary supplement
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Diamel Receives: Dietary Supplement: Diamel |
| B | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of blood concentrations of androgens at week 24
Measured: 24 weeks
Normalization of blood concentrations prolactin at week 24
Measured: 24 weeks
Normalization of blood concentrations of estrogens at week 24
Measured: 24 weeks
Normalization of blood concentrations of FSH at week 24
Measured: 24 weeks
Normalization of blood concentrations of LH at week 24
Measured: 24 weeks
Secondary outcomes (7)
Regularization of the menstrual cycle at week 24.
Measured: 24 weeks
Reappearance of ovulatory cycles at week 24
Measured: 24 weeks
Normalization of blood concentrations of insulin at week 24
Measured: 24 weeks
Normalization of blood concentrations of cholesterol at week 24
Measured: 24 weeks
Normalization of blood concentrations of triglycerides at week 24
Measured: 24 weeks
Normalization of blood concentrations of glucose at week 24
Measured: 24 weeks
Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mercedes Hernandez, MD, Principal investigator, "Ramón González Coro" Gynecologic and Obstetric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051024
- Sponsor's protocol ID
- CAT-0917-CU
- Status last verified
- May 2012
- First submitted
- 15 Jan 2010
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01051024
- Acronym / sponsor ID
- CAT-0917-CU
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 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.
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: DiamelDiamel |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Two of the following criteria:
- Signed informed consent
Key exclusion criteria (6 listed)
- Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
- Patients under other experimental treatment
- Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
- Treatment with vitamins within 7 days before treatment
- Treatment with dietary supplements within 60 days before treatment
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 |
|---|---|---|
| DiamelTwo Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks. | Dietary supplement | A |
| PlaceboTwo Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks. | Dietary supplement | B |
Primary outcome
Normalization of blood concentrations of androgens at week 24
Time frame: 24 weeks
Normalization of blood concentrations prolactin at week 24
Time frame: 24 weeks
Normalization of blood concentrations of estrogens at week 24
Time frame: 24 weeks
Normalization of blood concentrations of FSH at week 24
Time frame: 24 weeks
Normalization of blood concentrations of LH at week 24
Time frame: 24 weeks
7 secondary outcomes
Regularization of the menstrual cycle at week 24.
Time frame: 24 weeks
Reappearance of ovulatory cycles at week 24
Time frame: 24 weeks
Normalization of blood concentrations of insulin at week 24
Time frame: 24 weeks
Normalization of blood concentrations of cholesterol at week 24
Time frame: 24 weeks
Normalization of blood concentrations of triglycerides at week 24
Time frame: 24 weeks
Normalization of blood concentrations of glucose at week 24
Time frame: 24 weeks
Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.
Time frame: 24 weeks
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 May 2012.
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Mercedes Hernandez, MD principal investigator
"Ramón González Coro" Gynecologic and Obstetric Hospital
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 Diamel in people with Polycystic Ovary Syndrome, run by Catalysis SL at 1 site in Cuba.
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 5 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 May 2012. 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 Cuba. 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?
Normalization of blood concentrations of androgens at week 24 (time frame: 24 weeks). The study lists 5 primary outcomes in all. 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 May 2012.