What side effects are associated with this type of intervention?

Common treatments for Polycystic Ovary Syndrome (PCOS) that affect systemic androgen levels and hormonal balance include combined oral contraceptives (COCs), antiandrogens like spironolactone, and metformin. COCs can cause side effects such as nausea, weight gain, mood changes, and an increased risk of venous thromboembolism (VTE). Antiandrogens like spironolactone may lead to hyperkalemia, menstrual irregularities, and breast tenderness. Metformin can cause gastrointestinal issues like nausea, diarrhea, and abdominal discomfort. These side effects should be discussed with a healthcare provider to tailor the treatment to the individual patient's needs.

What prior FDA approvals exist?

The FDA has approved several treatments for managing symptoms of Polycystic Ovary Syndrome (PCOS) that affect androgen levels and hormonal balance. Combined oral contraceptives (COCs) are commonly used to regulate menstrual cycles and reduce androgen levels, thereby improving symptoms like hirsutism and acne. Antiandrogens such as spironolactone are often added to COC therapy to further reduce androgenic symptoms. Additionally, clascoterone, a topical antiandrogen, has been approved for the treatment of acne, which is often associated with PCOS. Metformin, although primarily used for insulin resistance, has also been utilized off-label to manage PCOS symptoms by improving menstrual regularity and reducing androgen levels.

What other types of research exist?

Promising novel alternatives to supplements for PCOS patients include hormonal therapies such as combined oral contraceptives, anti-androgens like spironolactone, and insulin-sensitizing agents like metformin. These treatments can help manage androgen levels and improve hormonal balance.

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Group Two: PCOS with No Hormonal Birth Control for Polycystic Ovary Syndrome

N/A

Waitlist Available

Research Sponsored by Zenchi, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves women with PCOS taking a daily supplement. The study will monitor changes in their symptoms like menstrual cycle regularity, acne, and mood over several months. The goal is to see if the supplement helps balance hormones and improve overall well-being.

Who is the study for?

This trial is for women aged 18-36 with PCOS, who are generally healthy and have a stable lifestyle without plans to change their diet, exercise, or hormonal birth control use. Participants must not be pregnant, attempting pregnancy, smokers, or have certain medical conditions like uncontrolled diseases or recent gynecological treatments.

What is being tested?

The study tests Elix Daily Harmony and Cycle Balance supplements on PCOS symptoms over 6 months. It's virtual and open-label with two groups: one using hormonal birth control and the other not. They'll take daily supplements and complete regular questionnaires about menstrual cycle changes, mood swings, acne etc.

What are the potential side effects?

While specific side effects aren't listed in the provided information for Elix Daily Harmony and Cycle Balance supplements, participants will likely monitor any adverse reactions such as digestive issues or skin irritations through the questionnaires.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To examine the effect of Daily Harmony and Elix Cycle Balance on acne as a symptom of hyperandrogenism. [Time Frame: Baseline to Week 24]

To examine the effect of Daily Harmony and Elix Cycle Balance on acne measure via expert skin grading. [Time Frame: Baseline to Week 24]

To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24]

Secondary study objectives

To examine the effect of Daily Harmony and Elix Cycle Balance on PCOS-associated symptoms. [Time Frame: Baseline to Week 24]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Group Two: PCOS with No Hormonal Birth ControlActive Control2 Interventions

All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.

Group II: Group One: PCOS & Hormonal Birth ControlActive Control2 Interventions

All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Polycystic Ovary Syndrome (PCOS) focus on regulating androgen levels and hormonal balance. Combined oral contraceptives (COCs) regulate menstrual cycles and reduce androgen levels, helping manage symptoms like hirsutism and acne. Antiandrogens, such as spironolactone, block androgen receptors, reducing the effects of excess androgens. Metformin improves insulin sensitivity, which can indirectly lower androgen levels and aid in weight management. These treatments are crucial for PCOS patients as they address the hormonal imbalances and hyperandrogenism central to the condition, thereby improving symptoms and overall quality of life.

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