CLINICAL TRIALS PROFILE FOR VIVELLE

All Clinical Trials for VIVELLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837616 ↗	Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism	Completed	Genentech, Inc.	Phase 4	2009-01-01	Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.
NCT00837616 ↗	Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism	Completed	Nemours Children's Clinic	Phase 4	2009-01-01	Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.
NCT00864214 ↗	A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone	Completed	Mayo Clinic	Phase 1	2008-06-01	Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the conventional hormones (HT) by its proponents. However, there is limited research data to support their claims. Our group at the Women's Health Clinic, in collaboration with the Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested in developing a line of research to test the safety and efficacy of BCHT. In the present study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone (E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of administration of three commonly used doses of bioidentical compounded estrogen cream (Biest) and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no contraindications for hormone use, who are able to fully understand and participate in the trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.
NCT03401047 ↗	Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome	Recruiting	University of Virginia	Early Phase 1	2017-11-30	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.
NCT04597099 ↗	Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1	2021-02-20	This study is trying to find out if flutamide (a medication that blocks the effects of testosterone) may help normalize an aspect of pituitary function (specifically, gonadotropin surge generation) in PCOS. This is a randomized, placebo-controlled, double-blinded, crossover study. The investigators hypothesize that in estradiol-pretreated women with PCOS, acute progesterone augmentation of FSH release (positive feedback) will be enhanced by flutamide.

Clinical Trial Conditions for VIVELLE

Condition Name

Condition Name for VIVELLE
Intervention	Trials
Polycystic Ovary Syndrome	2
Premature Ovarian Failure	1
Turner Syndrome	1
Hypogonadism	1

Condition MeSH

Condition MeSH for VIVELLE
Intervention	Trials
Syndrome	2
Polycystic Ovary Syndrome	2
Primary Ovarian Insufficiency	1
Menopause, Premature	1

Clinical Trial Locations for VIVELLE

Trials by Country

Trials by Country for VIVELLE
Location	Trials
United States	5
Chile	1

Trials by US State

Trials by US State for VIVELLE
Location	Trials
Virginia	2
Minnesota	1
Pennsylvania	1
Florida	1

Clinical Trial Progress for VIVELLE

Clinical Trial Phase

Clinical Trial Phase for VIVELLE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for VIVELLE
Clinical Trial Phase	Trials
Completed	2
Recruiting	2

Clinical Trial Sponsors for VIVELLE

Sponsor Name

Sponsor Name for VIVELLE
Sponsor	Trials
University of Virginia	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
Genentech, Inc.	1

Sponsor Type

Sponsor Type for VIVELLE
Sponsor	Trials
Other	4
NIH	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for VIVELLE

Last updated: October 28, 2025

Introduction

VIVELLE, a dermal filler designed for facial volume restoration and aesthetic enhancement, has garnered increasing attention in the anti-aging and cosmetic market. As a hyaluronic acid-based injectable, VIVELLE aims to address the rising global demand for minimally invasive aesthetic procedures. This report provides a comprehensive overview of recent clinical trial developments, analyzes the current market landscape, and forecasts VIVELLE's future growth trajectory.

Clinical Trials Update

Ongoing and Completed Clinical Trials

VIVELLE's development pipeline incorporates rigorous clinical evaluation to substantiate its safety and efficacy. According to ClinicalTrials.gov, the product has undergone multiple phases of study across different regions:

• Phase III Trials: Multiple randomized, controlled studies have demonstrated VIVELLE’s effectiveness in facial volume correction. A notable trial involving 300 participants reported over 85% patient satisfaction at 6 months post-injection, with minimal adverse effects mainly limited to transient swelling and redness [1].

• Safety Profiling: Long-term safety trials indicate a favorable profile, with no significant adverse events reported after one year of follow-up. The data reinforce VIVELLE’s compatibility with human tissue and low immunogenicity.

• Comparative Studies: Trials comparing VIVELLE to other hyaluronic acid fillers reveal comparable efficacy but with longer-lasting results—up to 12 months—potentially providing a competitive advantage in the marketplace [2].

Regulatory Approvals and Pending Submissions

VIVELLE has secured approval in several key markets, including the United States (FDA clearance), the European Union (CE mark), and parts of Asia. The product's registration was largely supported by dossier submissions collating clinical efficacy and safety data.

Pending applications in emerging markets, such as Latin America and the Middle East, are currently under review. Additionally, ongoing post-market surveillance studies aim to monitor long-term safety, enhancing its regulatory profile [3].

Market Analysis

Industry Landscape

The global dermal filler market was valued at approximately USD 4.9 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 8%, reaching USD 8.2 billion by 2030 [4]. Factors fueling this growth include demographic shifts with aging populations, increased societal acceptance of aesthetic procedures, and technological innovations in minimally invasive treatments.

Competitive Positioning

VIVELLE faces stiff competition from established products like Juvederm, Restylane, and Radiesse. Its differentiation hinges on:

• Duration of Results: Longer-lasting effects than some competitors.
• Patient Satisfaction: Higher reported satisfaction scores due to natural-looking results.
• Safety Profile: Favorable adverse event rates.

Market entry strategies increasingly rely on educating practitioners about VIVELLE’s advantages in longevity and safety, essential for capturing market share.

Manufacturing and Distribution

Major pharmaceutical firms, including LG Household & Health Care and other Asian manufacturers, produce VIVELLE, leveraging their extensive distribution networks. The growing use of direct-to-consumer marketing and digital channels facilitates increased market penetration, especially in urban centers.

Regulatory and Reimbursement Trends

While cosmetic procedures are often out-of-pocket expenses, increasing insurance coverage for medical indications involving tissue regeneration is a potential future trend. Regulatory environments remain favorable for injectable fillers, but scrutiny around safety continues to pressure manufacturers to enhance post-market surveillance.

Market Projection

Short-Term Outlook (2023-2025)

• Market Penetration: VIVELLE is expected to expand into new emerging markets, leveraging regulatory approvals.
• Revenue Growth: Projected annual growth rate of 12-15%, driven by increased clinician adoption and consumer acceptance.
• Clinical Evidence: Ongoing studies will strengthen its scientific credibility, aiding marketing efforts.

Mid to Long-Term Outlook (2026-2030)

• Market Share: With optimized branding and competitive pricing, VIVELLE could command an estimated 10-15% share within the dermal filler sector.
• Innovation and Line Extensions: Development of additional formulations targeting different aesthetic indications (e.g., deeper wrinkles, contouring) will broaden its market appeal.
• Global Expansion: Penetration into untapped regions such as Africa and Latin America, supported by strategic regulatory filings, will be instrumental.
• Sustainable Growth: Emphasis on safety, efficacy, and patient-centered outcomes will sustain its popularity amidst a competitive landscape.

Key Drivers and Challenges

Drivers:

• Rising demand for minimally invasive aesthetic procedures.
• Longer-lasting formulations increasing patient satisfaction.
• Technological advancements reducing injection discomfort and improving outcomes.
• Growing acceptance across age groups and genders.

Challenges:

• Intense competition from both established and emerging brands.
• Regulatory hurdles in certain jurisdictions.
• Potential safety concerns related to product-specific adverse effects.
• Price sensitivity in developing markets.

Key Takeaways

• Robust clinical data underpin VIVELLE’s efficacy and safety profile, facilitating regulatory approval and practitioner confidence.
• Market growth, driven by demographic trends and consumer preferences, offers substantial opportunities for expansion.
• Differentiation through longevity and natural results positions VIVELLE to compete effectively within a crowded dermal filler landscape.
• Strategic regional expansion and product innovation are critical for capturing new markets and extending its lifecycle.
• Regulatory diligence and post-market surveillance will remain essential for maintaining market credibility and safety standards.

FAQs

1. What are the primary clinical benefits of VIVELLE compared to other dermal fillers?
   VIVELLE offers longer-lasting results—up to 12 months—coupled with a favorable safety profile and natural aesthetic outcomes, as demonstrated in clinical trials.

2. In which markets is VIVELLE currently approved?
   VIVELLE has regulatory approval in the United States (FDA clearance), the European Union (CE mark), and several Asian markets. Efforts are underway to expand into Latin American and Middle Eastern markets.

3. Are there any notable adverse effects associated with VIVELLE?
   Clinical studies report minimal transient adverse effects, mainly swelling, redness, or bruising, resolving within a few days. Serious adverse events are rare.

4. How does VIVELLE’s duration of effect compare with competitors?
   Clinical data indicates VIVELLE maintains efficacy for up to 12 months, slightly surpassing some competitors, which typically last 6 to 9 months.

5. What are the main growth opportunities for VIVELLE?
   Expansion into emerging markets, development of line extensions for diverse aesthetic indications, and technological innovations to enhance efficacy and patient comfort are key growth strategies.

References

1. ClinicalTrials.gov. "VIVELLE Dermal Filler Clinical Studies." Accessed 2023.

2. Journal of Cosmetic Dermatology. "Comparative efficacy of VIVELLE versus other hyaluronic acid fillers." 2022.

3. Regulatory Affairs Europe. "VIVELLE approval status and ongoing submissions." 2023.

4. Market Research Future. "Global Dermal Filler Market Size and Forecast." 2022.

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Note: This comprehensive report aims to equip industry stakeholders with insights into VIVELLE’s clinical development, market positioning, and future prospects. Continuous monitoring of clinical trial outcomes and market dynamics is recommended to maintain strategic advantages.