37 Participants Needed

Estradiol for Polycystic Ovary Syndrome

(CRM009 Trial)

MG
CM
Overseen ByChristopher McCartney, M.D.
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

One study suggests that maintaining a certain level of estradiol (a form of estrogen) in the blood can help induce ovulation in women with polycystic ovaries, which is a key concern in polycystic ovary syndrome.12345

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 R. McCartney, MD - Division ...

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

I am able and willing to agree to the study's procedures and risks.
I am a woman aged 18-30 with PCOS, showing signs of high male hormones and irregular periods.
I am a woman aged 18-30, have regular periods, and show no signs of excessive male hormones.
See 2 more

Exclusion Criteria

I am a female.
I am over 30 years old.
My hormone levels suggest I might have a specific adrenal gland condition.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Estradiol Administration

Participants receive transdermal estradiol patches applied daily to maintain serum estradiol levels of 250-400 pg/ml

7-9 days
Daily visits for patch application and monitoring

Monitoring and Data Collection

Daily blood draws and urine collection for hormone measurements; transvaginal ultrasound on study day 6

7-9 days
Daily visits for blood draws and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Estradiol
Trial Overview The study tests whether estradiol, a form of estrogen, affects the secretion of hormones involved in ovulation differently in women with PCOS compared to healthy controls. It measures luteinizing hormone as its main focus and follicle-stimulating hormone secondarily.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transdermal EstradiolExperimental Treatment1 Intervention
Subjects will undergo estradiol administration for up to 9 days. Transdermal estradiol patches will be applied each day by study staff during study days two through nine (patches deliver 0.1 mg/day for a total dose of up to 0.6 mg/day).

Estradiol is already approved in European Union, United States, Canada for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Estradiol for:
  • Menopausal symptoms
  • Hypoestrogenism
  • Osteoporosis prevention
  • Breast cancer palliation
  • Prostate cancer palliation
πŸ‡ΊπŸ‡Έ
Approved in United States as Estradiol for:
  • 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
πŸ‡¨πŸ‡¦
Approved in Canada as Estradiol for:
  • 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

Trials
802
Recruited
1,342,000+

Findings from Research

The combination pill of ethinyl estradiol (EE) and desogestrel (DSG) significantly improved hyperandrogenic symptoms, such as reduced Ferriman-Gallwey scores and lower serum testosterone levels, in women with polycystic ovary syndrome (PCOS) during the first 6 months of treatment.
However, after 12 months, no further improvements were observed, and the treatment did not adversely affect insulin sensitivity or body weight, indicating that while effective initially, the benefits may plateau over time.
Effects of ethinyl estradiol and desogestrel on clinical and metabolic parameters in Indian patients with polycystic ovary syndrome.Bhattacharya, SM., Ghosh, M., Basu, R.[2013]
Letrozole is as effective as human menopausal gonadotropin (HMG) in inducing ovulation and achieving pregnancy in patients with polycystic ovary syndrome (PCOS) who are resistant to clomiphene citrate, with similar ovulation rates (53.6% for letrozole vs 64.7% for HMG).
Letrozole has a lower incidence of ovarian hyperstimulation syndrome (2 cases) compared to HMG (12.5% incidence), making it a safer option for inducing ovulation in these patients.
Letrozole and human menopausal gonadotropin for ovulation induction in clomiphene resistance polycystic ovary syndrome patients: A randomized controlled study.Shi, S., Hong, T., Jiang, F., et al.[2022]
In a study of 80 infertile women with polycystic ovarian syndrome, letrozole was found to improve endometrial thickness compared to clomiphene citrate, suggesting better conditions for implantation.
While clomiphene citrate resulted in higher levels of dominant follicles and oestradiol, letrozole showed lower resistance and pulsatility indices, indicating a potentially more favorable environment for pregnancy.
Impact of letrozole versus clomiphene citrate on endometrial receptivity in Iraqi women with polycystic ovarian syndrome.Al-Obaidi, MT., Ali, ZH., Al-Saadi, WI., et al.[2022]

References

Effects of ethinyl estradiol and desogestrel on clinical and metabolic parameters in Indian patients with polycystic ovary syndrome. [2013]
Letrozole and human menopausal gonadotropin for ovulation induction in clomiphene resistance polycystic ovary syndrome patients: A randomized controlled study. [2022]
Impact of letrozole versus clomiphene citrate on endometrial receptivity in Iraqi women with polycystic ovarian syndrome. [2022]
Letrozole Compared With Clomiphene Citrate for Polycystic Ovarian Syndrome: A Systematic Review and Meta-analysis. [2023]
The polycystic ovary. I. Estradiol/testosterone ratio and the use of antiestrogens. [2013]
Ovulation rates in a stair-step protocol with Letrozole vs clomiphene citrate in patients with polycystic ovarian syndrome. [2022]
Comparing efficacy and safety of stair step protocols for clomiphene citrate and letrozole in ovulation induction for women with polycystic ovary syndrome (PCOS): a randomized controlled clinical trial. [2023]
Letrozole versus Clomiphene Citrate for Induction of Ovulation in Patients with Polycystic Ovarian Syndrome Undergoing Intrauterine Insemination. [2021]
Lipid metabolic studies in women with a polycystic ovary syndrome during treatment with a low-dose desogestrel-ethinylestradiol combination. [2019]
Effects of two antiandrogen treatments on hirsutism and insulin sensitivity in women with polycystic ovary syndrome. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Normalization of testosterone levels using a low estrogen-containing oral contraceptive in women with polycystic ovary syndrome. [2019]
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