Metformin for Sclerocystic Ovaries
This study is evaluating whether metformin may be a better treatment option for women with polycystic ovary syndrome than oral contraceptives.
See full descriptionAbout the trial for Sclerocystic Ovaries
Treatment Groups
This trial involves 2 different treatments. Metformin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for female patients between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Metformin will improve 1 primary outcome and 18 secondary outcomes in patients with Sclerocystic Ovaries. Measurement will happen over the course of 6 months after each intervention.
Who is running the study
Principal InvestigatorPatient Q & A Section
What are the signs of sclerocystic ovaries?
Some signs of SCO are an irregular menstrual cycle, abnormal menstrual bleeding or spotting, dysmenorrhea (painful or heavy menstrual bleeding), hirsutism, ovarian cysts or masses. A complete blood count (CBC) should also be included as abnormal findings in patients with SOH.
What are common treatments for sclerocystic ovaries?
A large number of patients who are diagnosed with sclerocystic ovaries are treated with oral contraceptive therapy. This is typically due to the high incidence of coexisting endometritis or cervical cancer in such patients. The effectiveness of combined oral contraceptive therapy on this indication remains controversial.
How many people get sclerocystic ovaries a year in the United States?
Each year, around 22,300 US women will develop sclerocystic ovaries, accounting for 3% of new diagnoses of ovarian cancer. Of these new patients, around 2,800 will develop ovarian cancer by the age of 45.2 years. Sclerocystic ovaries are more common in postmenopausal women; approximately 75% of women who develop sclerocystic ovaries following menopause are more than 50 years of age. The number of new cases of a subgroup of ovarian cancers that are caused by sclerocystic ovaries is also increasing.
What is sclerocystic ovaries?
sclerocystic ovarian follicle maturation may result in a ovarian neoplasm called adenofibroma, usually a focal (less than 1 cm) single follicle weighing less than 1 g. The histopathology is unique in that one follicle is enclosed in scar tissue while the others are normal. This condition can mimic a carcinoma. However, adenofibromas have a benign behavior.
What causes sclerocystic ovaries?
Sclerocystic ovaries are mostly due to polycystic ovaries, and in women with the polycystic ovary phenotype, infertility can occur. The diagnosis of sclerocystic ovaries may be difficult and may require further imaging, particularly in patients over 30 years of age. Sclerocystic ovaries are also associated with the condition of hirsutism and other hormonal issues including polycystic ovary syndrome and hyperandrogenism.
Can sclerocystic ovaries be cured?
There is some evidence that laparoscopic drainage of granulosa cells to produce a follicle stimulating hormone surge can be successful in curing SOH. Further studies are needed to establish if this procedure reduces or cures the development of SOH related symptoms.
Does metformin improve quality of life for those with sclerocystic ovaries?
Metformin treatment is associated with a significant improvement in QoL over three months, particularly in body image and psychosexual symptoms. It is the first evidence of such a treatment response.
Have there been other clinical trials involving metformin?
Results of the present study imply that metformin is a safe and effective drug in patients with hirsutism. Metformin should be considered as first-line drug for hirsutism.
How quickly does sclerocystic ovaries spread?
This case demonstrates typical characteristics of LS, including hyperandrogenism, infertility and amenorrhoea, as well as LS characteristics including unilateral swelling around the ovaries and absence of other systemic effects apart from the signs and symptoms of excess androgens. The ovarian morphology was also typical of LS, albeit not as typical as in other case reports.
Has metformin proven to be more effective than a placebo?
Metformin improves the menstrual cycle in one-third of women treated for 5 months. The remaining two-third of the women experienced menstrual abnormalities or amenorrhea after 4 and/or even more years of metformin treatment. The duration of treatment is the most relevant factor in efficacy.
Does sclerocystic ovaries run in families?
An isolated case of SCO in the first degrees illustrates the existence of the syndrome in the general population. The fact that this isolation occurred in two other members of the same family who carry the D298P mutation suggests that an environmental factor may be involved in the pathogenetic mechanisms of the disease (idiopathic inheritance). This is not the first case of this kind, which may be indicative of a large number of asymptomatic carriers.
What is the survival rate for sclerocystic ovaries?
There is no evidence from the current literature to suggest that the survival rate of patients with sclerocystic ovaries is lower than that of patients with the same condition without the condition, because most sclerocystic ovaries either go into remission or become symptomatic. This is partly due to the fact that most sclerocystic ovaries are not as advanced as their presentation, or at present, can be diagnosed by clinical examination performed on women of child-bearing age without clinical or biochemical signs of hyperandrogenism. However, the presence of ovarian sclerostosis in women of child-bearing age with clinical or biochemical abnormalities, including polycystic ovary syndrome, has been reported.