Progesterone + Estradiol for Polycystic Ovary Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a short course of estrogen (Estrace) and progesterone affects hormone levels in girls with high male hormone levels who are at risk for developing polycystic ovary syndrome (PCOS). PCOS can cause issues such as irregular periods, excess hair growth, and difficulty getting pregnant. By understanding these hormone changes, researchers aim to find better treatments or even ways to prevent PCOS. Girls aged 8 to 18 with high testosterone or signs of excess male hormones might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new insights and preventive strategies for PCOS.
Will I have to stop taking my current medications?
Yes, if you are on hormonal medications or medications that affect the reproductive system, you must stop taking them at least 3 months before joining the study.
What prior data suggests that this treatment is safe for girls and women with PCOS?
Research has shown that using a combination of estrogen and progesterone is generally safe, though some risks exist. Studies have found that estrogen, as in birth control pills, can increase the risk of blood clots, particularly in veins. This risk depends on the dose and type of hormones used.
When combined, estrogen and progesterone may cause side effects like nausea or headaches in some women. These effects are typically mild and temporary.
Overall, while most people tolerate the treatment well, awareness of these potential risks is important, and discussing them with a healthcare provider is advised.12345Why are researchers excited about this trial?
Researchers are excited about using Progesterone and Estrace for treating Polycystic Ovary Syndrome (PCOS) because these hormones offer a potentially more natural approach to managing the condition. Unlike traditional treatments like birth control pills or metformin, which primarily aim to regulate menstrual cycles or insulin levels, this combination targets hormonal balance more directly. By using micronized progesterone and estradiol (the active form of Estrace), this treatment mimics the body's natural hormonal fluctuations, which could lead to improved symptom management with possibly fewer side effects. This approach offers a promising alternative for those seeking treatments that align more closely with the body's natural processes.
What evidence suggests that this trial's treatments could be effective for PCOS?
Research has shown that using estrogen and progesterone can help manage polycystic ovary syndrome (PCOS) by regulating periods and reducing high levels of male hormones. In this trial, participants will receive a combination of Estrace (estrogen) and progesterone. Studies have found that treatments with low doses of estrogen and various types of progesterone can restore normal menstrual cycles in women with PCOS. These treatments can also improve symptoms like excess facial and body hair caused by high testosterone levels. Additionally, progesterone levels can predict pregnancy outcomes for women with PCOS. This evidence suggests that using estrogen and progesterone together could effectively address some main issues of PCOS.678910
Who Is on the Research Team?
Chris McCartney, MD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for girls aged 8 to 18 with high male hormone levels, specifically testosterone >0.4 ng/mL or signs of excess hair growth. They must have normal lab results except for those related to high male hormones and weigh over 31 kg. Girls can't join if they've had certain cancers, are on hormonal treatments, pregnant/breastfeeding, smoke cigarettes, or have specific medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive estrogen and progesterone to assess the sensitivity of the GnRH pulse generator
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Estrace
- Progesterone
Trial Overview
The study tests how a week-long treatment with estrogen (estrace) and progesterone affects the GnRH pulses in young females with elevated male hormones. The goal is to understand the development of PCOS and potential treatments by monitoring changes in hormone patterns.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Estrace, 0.5-1 mg once a day Micronized progesterone powder (Spectrum Chemical Manufacturing Corporation, Irving, CA), Three times a day at 0700, 1500, and 2300 hr
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Cyclic Progesterone Therapy in Androgenic Polycystic Ovary ...
This pilot study's purpose was to document 6-month experience changes in a woman with PCOS taking cyclic progesterone therapy.
Estrogen Receptors in Polycystic Ovary Syndrome - PMC
This article focuses on the recent progress in PCOS caused by the abnormal expression of estrogen and ERs in the ovaries and uterus.
An Update on Contraception in Polycystic Ovary Syndrome
Containing low doses of estrogen and different types of progestin, COCs restore menstrual cyclicity, improve hyperandrogenism, and provide additional benefits ...
Exploration of the value of progesterone and progesterone ...
The progesterone level is significantly better than the P/E2 ratio in predicting the pregnancy outcome of PCOS patients, especially in ultralong ...
Comparison of the Outcomes of Polycystic Ovary Syndrome ...
Conclusion: This study indicates that COCs are most effective for menstrual regularity, anti-androgens provide the best results for reducing ...
Adverse Effects of the Common Treatments for Polycystic ...
AA use has been associated with hepatic toxicity that could be fatal (17). The risk and nature of these side effects must be considered when choosing therapies.
An Update on Contraception in Polycystic Ovary Syndrome
COCs increase the risk of venous thromboembolism (VTE), related both to the dose of estrogen and the type of progestin involved. Arterial thrombotic events ...
Contraception in Women With Polycystic Ovary Syndrome
Currently available evidence indicates an increased relative risk of venous thrombosis associated with OCs varying among different formulations. Arterial ...
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uptodate.com
uptodate.com/contents/combined-estrogen-progestin-oral-contraceptives-patient-selection-counseling-and-useCombined estrogen-progestin oral contraceptives
The data regarding safety of ... polycystic ovary syndrome or nonclassic congenital adrenal hyperplasia due to 21-hydroxylase deficiency.
Polycystic Ovarian Syndrome Medication
Ethinyl estradiol combined with drospirenone (Yasmin) has a progestin that acts as an antiandrogen and thus may add antiandrogenic effects. Withdrawal bleeding ...
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