Estradiol for Polycystic Ovary Syndrome
(CRM009 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be in general good health, except for certain conditions like PCOS and adequately-treated hypothyroidism, which suggests that some medications might be allowed.
What data supports the effectiveness of the drug Estradiol for treating polycystic ovary syndrome?
Is estradiol safe for treating polycystic ovary syndrome?
The research does not provide specific safety data for estradiol in treating polycystic ovary syndrome, but a study on a similar hormone treatment (desogestrel and ethinylestradiol) showed only moderate changes in lipid levels, suggesting it may be generally safe. However, more specific studies on estradiol are needed to confirm its safety.36789
How does the drug Estradiol differ from other treatments for polycystic ovary syndrome?
Estradiol is unique because it is a form of estrogen that can help balance hormone levels in women with polycystic ovary syndrome (PCOS), potentially improving symptoms like irregular periods and excess hair growth. Unlike some other treatments that focus on inducing ovulation or reducing androgens, Estradiol primarily works by supplementing estrogen levels, which may help regulate the menstrual cycle and improve overall hormonal balance.1351011
What is the purpose of this trial?
The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.
Research Team
Christopher M McCartney, MD
Principal Investigator
University of Virginia
Eligibility Criteria
This trial is for adult women aged 18-30 with Polycystic Ovary Syndrome (PCOS), characterized by excess male hormones and irregular periods, but no other health issues. Participants must avoid pregnancy and have regular menstrual cycles if they're in the control group without PCOS signs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Estradiol Administration
Participants receive transdermal estradiol patches applied daily to maintain serum estradiol levels of 250-400 pg/ml
Monitoring and Data Collection
Daily blood draws and urine collection for hormone measurements; transvaginal ultrasound on study day 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Estradiol
Estradiol is already approved in European Union, United States, Canada for the following indications:
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
- Moderate to severe vasomotor symptoms due to menopause
- Vulvar and vaginal atrophy due to menopause
- Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
- Prevention of postmenopausal osteoporosis
- Palliative treatment of breast cancer
- Palliative treatment of prostate cancer
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor