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ObesityPhase 4NCT01475019

The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

A Phase 4 study testing Orlistat, Sibutramine and Diet and physical exercise in people with Obesity and Polycystic Ovaries Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The first aim of the investigators study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls. Read more about this study

Who is it for?
Ages 18 to 39 years, women only
Conditions the study is for
Obesity, Polycystic Ovaries Syndrome
What is being tested?
Orlistat, Sibutramine and Diet and physical exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGreece
Study dates
Jan 2004to Dec 2012
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 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • premenopausal,
  • nonpregnant,
  • nonlactating,
  • overweight and obese women

Who cannot join

  • classical 21-hydroxylase deficiency,
  • hyperprolactinemia,
  • adrenal or ovarian tumor and Cushing's disease

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Aristotle University of Thessaloniki Medical School

    Thessaloniki, Thessaloniki, 54124

Other trials in Greece

About this study

Official title: The Effect of Weight Loss With Orlistat or Sibutramine Administration , Hypocaloric Diet and Physical Exercise , on AMH Levels, in Women With Polycystic Ovary Syndrome

The first aim of the investigators study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.

The other aim of the investigators study, was to examine the effect of hypocaloric diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).

Read the detailed description

The first aim of our study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.

The study included sixty one (61) women with PCOS (mean age: 26.11±6.86 and mean body mass index: 34.83±6.39), matched for age and body mass index (BMI) with twenty (20) obese women without PCOS (mean age: 26.95±4.77 and mean BMI: 36.79±6.98). Diagnosis of PCOS was based on the 2003 Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus criteria.

Briefly, a moderate daily physical activity and a normal-protein, energy restricted diet were prescribed based on a calculated individual basal metabolic rate (BMR) of all women (BMR-600 kcal/d), for a period of 24 weeks. In addition, orlistat (Xenical, Roche S.A., Greece; 120 mg, 3 times per day) was administered before each meal, for 24 weeks. At baseline, week 12, and week 24, at 9:00 AM, after an overnight fast, subjects were weighed. Waist and hip circumferences were measured in duplicate. Blood samples were collected and the basal serum levels of AMH, FSH, LH, PRL, T, D4A, DHEAS, 17a-hydroxyprogesterone (17a-OHP), SHBG, glucose, and insulin were measured. AMH concentrations were measured with an enzymatically amplified two-sided immunoassay [DSL-10-14400 Active Müllerian Inhibiting Substance/AMH enzyme-linked immunosorbent assay (ELISA) kit, DSL Laboratories, Webster, TX]. The theoretical sensitivity of the method is 0.006 ng/ml, the intra-assay coefficient of variation for high values is 3.3% and the interassay coefficient of variation for high values is 6.7%.

We also studied the changes of mean number of follicles (expressed as the mean number of follicles of both ovaries= follicles of right ovary+ follicles of left ovary/2) and mean ovarian volume (expressed as the mean volume of both ovaries= volume of right ovary+ volume of left ovary/2).

The other aim of our study, was to examine the effect of hypocaloric diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).

Outpatients, premenopausal, nonpregnant, nonlactating, overweight and obese women (body mass index, BMI >27), 18 years of age and older with PCOS were recruited for this study. The study included fifty seven (57) women with PCOS (mean age: 26.11±6.86 and mean body mass index: 34.83±6.39) who, besides diet and exercise, received Sibutramine treatment, matched for age and body mass index (BMI) with nineteen (19) obese women with PCOS (mean age: 26.95±4.77 and mean BMI: 36.79±6.98) treated only with diet and exercise. Diagnosis of PCOS was based on the 2003 Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus criteria . Women with no classical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing's disease were excluded by the appropriate tests. Other exclusion criteria were hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment, such as antihypertensive drugs, selective serotonin reuptake inhibitor or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, luteinizing hormone (LH) release hormone agonist) and insulin-sensitizing agents (metformin, pioglitazone, rosiglitazone) that may interact with insulin sensitivity and lipid profile.

Briefly, all patients were placed in a hypocaloric diet plus sibutramine (10mg per day) for the first month and then on a hypocaloric diet plus sibutramine (10mg per day) or hypocaloric diet only for the subsequent 6 months. A moderate physical activity (3 hours per week) and a normal-protein, energy restricted diet were prescribed based on a calculated individual basal metabolic rate (BMR) of all women (BMR-600 kcal/d), for a period of 24 weeks.

At baseline, week 12, and week 24, at 9:00 AM, after an overnight fast, subjects were weighed. Waist and hip circumferences were measured in duplicate. Blood samples were collected and the basal serum levels of AMH, FSH, LH, PRL, T, D4A, DHEAS, 17a-hydroxyprogesterone (17a-OHP), SHBG, glucose, and insulin were measured. AMH concentrations were measured with an enzymatically amplified two-sided immunoassay [DSL-10-14400 Active Müllerian Inhibiting Substance/AMH enzyme-linked immunosorbent assay (ELISA) kit, DSL Laboratories, Webster, TX].

Being tested
Orlistat, Sibutramine, Diet and physical exercise
Keywords
Obesity, Polycystic Ovaries Syndrome, Orlistat, Sibutramine, Androgen levels, Insulin resistance
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrlistatDrug

    Tablet, 120 mg, three times daily, for six months

  • SibutramineDrug

    Tablet, 10 mg, once daily, for six months

  • Diet and physical exerciseBehavioural

    Hypocaloric diet and regular physical exercise

Study groups in NCT01475019
Study groupRoleWhat they receive
PCOS obese OrlistatExperimentalObese PCOS women treated with Orlistat, diet and physical exercise
Receives: Drug: Orlistat
Obese OrlistatExperimentalObese women (non PCOS) treated with Orlistat, diet and physical exercise
Receives: Drug: Orlistat
PCOS obese dietExperimentalObese PCOS women treated with diet and physical exercise
Receives: Behavioral: Diet and physical exercise
PCOS obese SibutramineExperimentalObese PCOS women treated with Sibutramine, diet and physical exercise
Receives: Drug: Sibutramine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti- Mullerian hormone (AMH) levels

    Measured: 6 months

Secondary outcomes (4)
  1. Weight loss

    Measured: 6 months

  2. Androgen levels

    Free androgen index, Testosterone, 17OH Progesterone, D4 Andostenedione, Testosterone to Androstenedione ratio

    Measured: 6 months

  3. Follicular number

    Mean follicular number

    Measured: 6 months

  4. Gonadotrophins

    Follicular Stimulating Hormone (FSH), Luteneizing Hormone (LH), LH to FSH ratio

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2011 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2010
  4. Study completionDec 2012 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01475019
Sponsor's protocol ID
A1732,2011
Status last verified
Nov 2011
First submitted
14 Nov 2011
Last updated
21 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Orlistat, Sibutramine and Diet and physical exercise in people with Obesity and Polycystic Ovaries Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 4 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: status not confirmed, as of the sponsor's last update on 21 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 Greece. 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?

Results are not available in the source record.

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?

Anti- Mullerian hormone (AMH) levels (time frame: 6 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 21 Nov 2011.

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