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Poly Cystic Ovary SyndromePhase 4NCT02789488

Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome

A Phase 4 study testing Fenugreek seeds extract 500 mg in people with Poly Cystic Ovary Syndrome, run by Chemical Resources.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Poly Cystic Ovary Syndrome
What is being tested?
Fenugreek seeds extract 500 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2013to Jul 2014
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 between 18-45 years of age and BMI less than 42
  • Diagnosed with PCOS
  • Adequate hepatic, renal and hematological functions
  • Patients willing to give informed consent in writing

Who cannot join

  • Males
  • Post menopausal women
  • Women with hysterectomy
  • Patients with congenital adrenal hyperplasia
  • Patients suffering from Cushing's syndrome
  • Patients diagnosed with androgen secreting tumors
Show all 9Show fewer
  • Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age)
  • Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction)
  • Pregnancy or desire for pregnancy or lactating mothers

About this study

Official title: Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome

Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins \& flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in the body.

Read the detailed description

Polycystic ovary syndrome is considered as clinical and public health consequence involving increase in number of cysts in women at reproductive age. These cysts are under-developed sacs in which eggs are developed. In PCOS, these sacs are unable to release an egg which means ovulation doesn't take place.

The estimated 5-10% prevalence of PCOS is reported in women of reproductive age. A study from Spain also reported that 28.3% prevalence rate of PCOS is among 113 overweight or obese women who were referred to an endocrinology clinic for weight loss. This data was compared with a previously reported prevalence of 6.5% which suggests that the prevalence of PCOS might be markedly increasing with obesity.

PCOS impacts significantly on various hormonal cycles. With PCOS, luteinizing hormone (LH) levels become higher than follicle stimulating hormone (FSH) levels. Because of this increase in LH levels, the LH surge does not take place and ovulation doesn't carry out which results in irregular menstrual cycle. The irregular menstrual period produces oligomenorrhea (few menstrual periods) or amenorrhea (no menstrual periods) and infertility due to irregular or lack of ovulation. PCOS also produces high levels of masculinizing hormones with symptoms of acne and hirsutism, hypermenorrhea involving heavy and prolonged menstrual periods and androgenic alopecia (increase hair thinning and diffused hair loss). The other metabolic syndromes associated with PCOS are increased risk of type 2 diabetes, high cholesterol levels and obesity.

These complications arise because of the genetically determined cause of the PCOS i.e. hyper- secretion of androgens from the ovary which favours excess luteinizing hormone (LH) secretion and insulin resistance. However, insulin resistance with or without a genetic mutation may be the initiator, followed by hyper-androgenism. Thus, insulin resistance is an important contributing factor to abnormal steroidogenesis in PCOS because hyper-insulinemia stimulates the pathway of insulin like growth factor-I (IGF-I) in theca cells of the ovary by cross-reacting with the receptors of IGF. Stimulation of the ovarian theca cells increases the production of androgens (eg, testosterone, androstenedione) which in turn, blocks the down-regulation of androgens by LH surge and leads to the hyper-androgenic environment in the ovary. Because of a decreased level of FSH relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and results in anovulation.

Treatments for PCOS are chosen based on woman's symptoms, age and future pregnancy plans which may include birth control pills to regulate menstruation, insulin-sensitizing medications, ovulation induction to treat infertility, androgen-blocking medications, topical anti-hair-growth medications, etc.

Standardized fenugreek (Trigonella foenum graecum) seed extract (Furocyst) plays an important role in the management of PCOS. It improves glucose-tolerance and insulin-sensitivity, thereby promoting weight loss and moderation of androgen levels in the blood. Standardized fenugreek seeds extract contains a group of furostanolic saponins, derived from fenugreek seeds by an innovative process. It contains rich variety of saponins and flavonoids which have been known to lower the blood lipid levels and play valuable role in improving insulin sensitivity. Standardized fenugreek seeds extract is a dual insulin-sensitizer. In the presence of high fiber furostanolic saponins, cells become more sensitive to insulin \& an increase in number of insulin receptor sites occurs. These receptor sites are responsive to insulin to stimulate the cells ability to burn glucose. This decrease in insulin resistance helps in the management of PCOS.

Considering the beneficial effects of standardized fenugreek seed extract, present study was conducted to evaluate the efficacy of fenugreek seeds extract in patients with poly cystic ovary syndrome by assessing reduction in ovarian volume and decrease in the number of ovarian cysts.

Being tested
Fenugreek seeds extract 500 mg

What participants receive

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

  • Fenugreek seeds extract 500 mgDietary supplement

    Also called Furocyst

    Furocyst one caps BID

Study groups in NCT02789488
Study groupRoleWhat they receive
FurocystOtherFurocyst one caps BID
Receives: Dietary Supplement: Fenugreek seeds extract 500 mg

What is being measured

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

  1. Reduction in Ovary volume as assessed by ultrasound

    volume in cubic cms

    Measured: 12 weeks

Timeline

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

  1. First posted3 Jun 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789488
Sponsor's protocol ID
CR001/PCOS-5-13
Status last verified
Sep 2013
First submitted
20 Apr 2016
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.

    PubMed 15788499
  • Schroder AK, Tauchert S, Ortmann O, Diedrich K, Weiss JM. [Insulin resistance in polycystic ovary syndrome]. Wien Klin Wochenschr. 2003 Dec 15;115(23):812-21. doi: 10.1007/BF03041041. German.

    PubMed 14740344
  • Hassanzadeh Bashtian M, Emami SA, Mousavifar N, Esmaily HA, Mahmoudi M, Mohammad Poor AH. Evaluation of Fenugreek (Trigonella foenum-graceum L.), Effects Seeds Extract on Insulin Resistance in Women with Polycystic Ovarian Syndrome. Iran J Pharm Res. 2013 Spring;12(2):475-81.

    PubMed 24250624

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fenugreek seeds extract 500 mg in people with Poly Cystic Ovary Syndrome, run by Chemical Resources.

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 9 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Reduction in Ovary volume as assessed by ultrasound (time frame: 12 weeks). 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 NCT02789488, which also lists 3 linked publications.

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 3 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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