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.
NCT04597099 ↗	Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion	Recruiting	University of Virginia	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
Hypogonadism	1
Menopause	1
PCOS	1

Condition MeSH

Condition MeSH for VIVELLE
Intervention	Trials
Polycystic Ovary Syndrome	2
Syndrome	2
Menopause, Premature	1
Hypogonadism	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
Genentech, Inc.	1
Nemours Children's Clinic	1

Sponsor Type

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

VIVELLE (estradiol transdermal system): Clinical-trial status, market analysis, and projection

Last updated: May 3, 2026

What is VIVELLE and what is its regulatory footprint?

VIVELLE is a brand of estradiol transdermal systems (topical estrogen) used for hormone therapy. In the U.S., it is marketed as a prescription product and competes in the menopausal hormone therapy patch segment.

How is VIVELLE positioned versus key alternatives?

The U.S. menopausal hormone therapy market includes:

• Transdermal estradiol patches (multiple brands and generics)
• Estradiol gels and sprays
• Oral estrogen products
• Menopausal hormone therapy combinations (where applicable by indication, patient need, and progesterone requirement)

From a competitive lens, VIVELLE competes on:

• Patch-based delivery and dosing flexibility
• Formulation differentiation (matrix vs reservoir, adhesion, wear time)
• Coverage and formulary access
• Net price after rebates and payer contracting

What clinical-trial evidence exists for VIVELLE specifically?

No fresh, brand-specific clinical-trial updates for VIVELLE were identified in the available public trial registries at the time of this report. VIVELLE’s clinical positioning historically relies on estradiol transdermal evidence and bioavailability/bridging approaches typical for patch formulations, rather than large ongoing phase programs uniquely for the brand.

What does the evidence imply for R&D risk and near-term pipeline activity?

Given the absence of brand-specific active trial signals, VIVELLE’s near-term growth is driven more by:

• Formulary placement for estradiol patches
• Patient switching behavior within transdermal estradiol classes
• Competitive pricing and contracting dynamics
• Supply and manufacturing reliability

This profile typically aligns with mature-cycle product economics rather than pipeline-led growth.

Where does VIVELLE sit in the patent and exclusivity cycle?

VIVELLE is an established brand with a mature market footprint. Transdermal estradiol patch products are commonly exposed to:

• Patent expirations and entry of authorized or generic equivalents
• Ongoing “at-risk” competition on pricing
• Payer preference shifts toward lower-cost options

A market-impact event in this segment is usually driven by:

• Generic/generic-competitor launch timing
• Interchangeability and formulary adoption
• Rebates and contracting pressure after entry

Market analysis: size, demand drivers, and competitive pressure

Demand drivers

Key demand drivers in menopausal hormone therapy include:

• Prevalence of menopausal symptoms in the target age population
• Ongoing clinical acceptance of transdermal estrogen in appropriate patients
• Preference for transdermal routes in patients who avoid oral estrogen due to tolerability and risk considerations

Supply-side and payer drivers

Competition in transdermal estradiol patches is structurally intense:

• Multiple brands and generics across the estradiol patch/generic landscape
• Payer-driven formulary narrowing and step edits
• Net price erosion after generic entry

Category dynamics

Estradiol transdermal products tend to maintain share because they align with patient preferences for steadier delivery and convenience. However, brand premium pricing compresses after competitor launches, especially where patches become standardized by dose deliverables.

How should investors and strategists project VIVELLE revenue?

Projection framework

A realistic projection for a mature estradiol patch brand should assume:

• Volume growth at low-single-digit or flat-to-slight decline depending on competitor intensity
• Net sales pressure from generics, authorized generics, and contracting dynamics
• Growth tied to payer mix and remaining brand differentiation

Three-scenario market projection (2026-2030)

Because VIVELLE’s brand-specific trial pipeline is not driving demand, projections should be built around share and price, not clinical breakthroughs. Below is a scenario model for VIVELLE net sales index (base-year indexed to 100).

Scenario	Assumptions (2026-2030)	Net sales index by 2030
Bear	Accelerated payer switching to lowest-cost patch/generic options; continued net price erosion	65-75
Base	Stabilization of formulary position with moderate pricing pressure; limited share loss	80-90
Bull	Strong payer retention, reduced competitive impact in key geographies; slower net price erosion	95-105

What drives upside vs downside

• Upside: contracting that preserves net price, durable payer coverage, and lower-than-expected conversion to generic alternatives
• Downside: step therapy expansion, formulary switching, and rapid competitive discounting post-launches in adjacent patch strengths

Breakeven logic for the business

For mature transdermal estrogen brands, breakeven tends to hinge on:

• Manufacturing cost structure and yield
• Loss of premium to lower-cost competitors
• Ability to maintain payer access at tolerable rebate levels

Commercial outlook: 12- to 24-month view

Over the next 12 to 24 months, VIVELLE’s market performance will likely be governed by:

• Payer formulary behavior in estradiol patch classes
• Competitive pricing and rebate dynamics
• Patient adherence and pharmacy channel stocking preferences
• Any class-level shifts toward lower-cost alternatives

With no brand-specific new clinical trial momentum, the brand outlook should be treated as a commercial execution story rather than a clinical adoption story.

Key takeaways

• VIVELLE is a mature estradiol transdermal system competing in an overcrowded menopausal hormone therapy patch category.
• No brand-specific active clinical-trial updates were identified in the available public sources for this report, so near-term growth is not driven by new clinical evidence.
• Market performance is dominated by payer contracting and generic/generic-competitor pressure, which typically drives net price erosion and share drift over time.
• Revenue projections (indexed to 100 in base year): Bear 65-75 by 2030, Base 80-90, Bull 95-105, with outcomes driven by formulary retention vs switching speed.

FAQs

1. What drug is VIVELLE?
   VIVELLE is estradiol transdermal therapy (estradiol patch).

2. What clinical-trial updates are driving VIVELLE demand?
   None were identified as brand-specific new phase activity in the available public trial registries for this report period.

3. What is VIVELLE competing against most directly?
   Competes against other estradiol transdermal systems and lower-cost estradiol patch options, plus alternative estradiol formulations within hormone therapy.

4. How should revenue projections be modeled for VIVELLE?
   Model around net price erosion and formulary share retention, not clinical adoption from new trials.

5. What is the biggest swing factor for VIVELLE in the next 1 to 2 years?
   Payer formulary access and rebate pressure as competitors with lower cost structures expand.

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References

[1] U.S. Food and Drug Administration. Approved Drug Products and Clinical Pharmacology Review(s) for estradiol transdermal systems (product labeling and regulatory documentation). https://www.accessdata.fda.gov
[2] ClinicalTrials.gov. Estradiol transdermal systems search results (public trial registry records). https://clinicaltrials.gov
[3] National Library of Medicine. PubMed records and related literature on estradiol transdermal therapy and menopausal hormone therapy (contextual category evidence). https://pubmed.ncbi.nlm.nih.gov