CLINICAL TRIAL

Metformin for Sclerocystic Ovaries

Recruiting · 18 - 65 · Female · Charlottesville, VA

This study is evaluating whether metformin may be a better treatment option for women with polycystic ovary syndrome than oral contraceptives.

See full description

About 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Oral combined hormonal contraceptives
DRUG
Metformin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Oral combined hormonal contraceptives
DRUG
Metformin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Women aged 40-49 years who have PCOS are considered to have PCOS if they have current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea or irregular menstruation (substantially inconsistent menstrual cycle length) show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months after each intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months after each intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Fasting glucose
6 MONTHS AFTER EACH INTERVENTION
mg/dL
Fasting insulin
6 MONTHS AFTER EACH INTERVENTION
uIU/mL
waist-to-hip ratio
6 MONTHS AFTER EACH INTERVENTION
It is a ratio of waist and hip circumference
2-hour glucose level during oral glucose tolerance test
6 MONTHS AFTER EACH INTERVENTION
mg/dL
Matsuda index
6 MONTHS AFTER EACH INTERVENTION
It is an index to assess insulin sensitivity.
Body mass index
6 MONTHS AFTER EACH INTERVENTION
kg/meter square
See More

Who is running the study

Principal Investigator
S. H. K.
Prof. Su Hee Kim, MD
University of Virginia

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Sclerocystic Ovaries by sharing your contact details with the study coordinator.