CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL

All Clinical Trials for ETHINYL ESTRADIOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000897 ↗	A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00001221 ↗	Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1987-09-01	Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries. In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period. This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups. 1. Group one will receive low dose estrogen 2. Group two will receive growth hormone 3. Group three will receive both low dose estrogen and growth hormone 4. Group four will receive a placebo "sugar pill" Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16. Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.
NCT00004763 ↗	Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism	Completed	Baylor College of Medicine	Phase 2	1993-01-01	OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
NCT00004763 ↗	Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism	Completed	National Center for Research Resources (NCRR)	Phase 2	1993-01-01	OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	University of Alabama at Birmingham	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	National Center for Research Resources (NCRR)	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
NCT00033358 ↗	Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-02-01	Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.

Clinical Trial Conditions for ETHINYL ESTRADIOL

Condition Name

Condition Name for ETHINYL ESTRADIOL
Intervention	Trials
Contraception	57
Healthy	26
Female Contraception	11
HIV Infections	9

Condition MeSH

Condition MeSH for ETHINYL ESTRADIOL
Intervention	Trials
HIV Infections	13
Polycystic Ovary Syndrome	10
Syndrome	8
Dysmenorrhea	8

Clinical Trial Locations for ETHINYL ESTRADIOL

Trials by Country

Trials by Country for ETHINYL ESTRADIOL
Location	Trials
United States	474
China	34
Germany	28
Canada	19
United Kingdom	12

Trials by US State

Trials by US State for ETHINYL ESTRADIOL
Location	Trials
California	35
Florida	33
Texas	28
Pennsylvania	24
Arizona	22

Clinical Trial Progress for ETHINYL ESTRADIOL

Clinical Trial Phase

Clinical Trial Phase for ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
Completed	176
Recruiting	23
Unknown status	15

Clinical Trial Sponsors for ETHINYL ESTRADIOL

Sponsor Name

Sponsor Name for ETHINYL ESTRADIOL
Sponsor	Trials
Bayer	20
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	17
Bristol-Myers Squibb	15

Sponsor Type

Sponsor Type for ETHINYL ESTRADIOL
Sponsor	Trials
Industry	200
Other	111
NIH	16

Last updated: April 24, 2026

Ethinyl Estradiol (EE): Clinical Trials Update, Market Analysis, and Projection

What clinical trial activity exists for Ethinyl Estradiol (EE)?

Ethinyl estradiol (EE) is a long-established synthetic estrogen used across contraception and menopausal symptom therapies. Trial activity in the public domain is predominantly tied to combination regimens (with progestins) and delivery systems (tablets, rings, patches, and long-acting formulations). Standalone EE development programs are limited; most new registrations and clinical evaluations occur as line extensions rather than new active-molecule introductions.

Observed pattern across EE clinical studies (public registries):

• Indication areas: contraception (cycle control, bleeding management), endometriosis-related symptom control via hormonal regimens (mostly in combination), and vasomotor symptom regimens (often in combination with progestins depending on endometrial protection needs).
• Trial focus: pharmacokinetics (PK), pharmacodynamics (PD), safety/tolerability (including thromboembolic and breast-related adverse event monitoring), and bleeding pattern characterization.
• Endpoints: ovulation suppression, endocrine markers (estradiol/estrone levels), uterine bleeding patterns, and tolerability.

Key business implication: the bulk of “EE clinical trials” activity does not map to a single product pipeline for EE monotherapy. It maps to product-formulation and label-expansion work in combination products, which typically compresses exclusivity value and shifts value capture to formulation IP, device/route IP, and manufacturing/process.

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Where does Ethinyl Estradiol sit in the market?

EE is one of the most widely used estrogens in modern pharmacotherapy. Commercial value is driven by:

• Mass-market contraception (combined oral contraceptives, extended-cycle regimens)
• Hormone replacement therapy positioning (selected formulations and geographic label differences)
• Generic availability (EE itself and many fixed-dose combinations are off-patent in most markets)
• Brand differentiation that remains at the level of progestin selection, dosing schedule, and regimen design, not the EE molecule

Market structure

• Active ingredient commoditization: EE’s molecule is broadly genericized globally in oral and many topical products. The competitive advantage concentrates in combination architecture and product lifecycle management.
• Regimen-level differentiation: manufacturers compete on bleeding profile, cycle length, tolerability, and route (oral vs transdermal vs vaginal).
• Supply chain: EE is widely manufactured; pricing is shaped more by generic competition than by clinical differentiation.

Indicative market dynamics (industry-wide):

• Volume demand stays resilient because contraception is a large, recurring consumer category.
• Pricing pressure is sustained where multiple generic entrants exist.
• Originator premium tends to persist only in select branded regimens with differentiated dosing schedules and strong payer/provider uptake.

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What is the investment-grade view of EE pipeline risk?

EE pipeline risk is structurally low for the molecule and higher for the specific product concept.

Risk drivers:

• Regulatory and safety constraints: EE use is linked to estrogen class risks (notably thromboembolic risk), and labeling constraints reduce the space for new claims.
• Competitive saturation: the market has many fixed-dose combinations and multiple generics; incremental clinical value must translate into measurable regimen benefits (bleeding control, tolerability, adherence).
• Exclusivity limitations: when EE is off-patent, value capture depends on secondary IP (formulation, route, dosing regimen, manufacturing changes, and method-of-use claims that can survive regulatory scrutiny).

Opportunity concentration:

• Extended-cycle and low-dose regimen refinements that improve adherence and bleeding tolerability.
• Route and adherence platforms (patch/ring formulations and clinician-administered routes where available).
• Regional label work where payer coverage and guideline inclusion can shift demand.

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How does the legal/IP landscape typically shape EE commercial outcomes?

For EE, exclusivity is usually fragmented:

• Composition-of-matter for EE itself is long expired in most markets.
• Combination patents (EE + specific progestin doses, titration regimens, and schedule design) drive practical exclusivity.
• Secondary patents may include:
  • formulation (dosage form engineering)
  • manufacturing process or particle/crystal form adjustments where relevant
  • dosing schedule algorithms (extended-cycle regimens)
  • packaging or administration methods (especially for adherence-focused delivery systems)

Business outcome: market entry is usually feasible after generic approval, but brand share depends on ongoing regimen evolution, payer contracting, and physician adoption rather than on new EE molecular breakthroughs.

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How should EE market projections be modeled?

A practical projection for EE should model regimen demand rather than EE-only demand. The right approach is to treat EE as a component used across:

• combined oral contraceptives (COCs)
• combined patch/ring products
• selected hormone therapy regimens where EE is used in combination or as part of a regimen

Projection logic (what drives direction):

• Contraception adoption and adherence (affects volume of COCs and cycle-control products)
• Shift toward extended-cycle regimens (can increase per-user prescription value even if total estrogen exposure per year stays similar)
• Generics penetration (puts downward pressure on realized prices)
• Guideline changes and formulary decisions (impact uptake)

Scenario mechanics

• Base case: stable contraception volumes with gradual price erosion in generic-heavy markets; moderate share gains for higher adherence regimens where payers incentivize them.
• Bear case: intensified generic competition in major markets reduces realized prices; formulary restrictions reduce branded share.
• Bull case: continued uptake of adherence and bleeding-optimized regimens increases share of products that combine EE with favorable progestins and dosing schedules; payer coverage expands for select regimens.

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What revenue and growth should be expected?

A direct dollar forecast for “Ethinyl Estradiol” as a standalone active ingredient is not decision-grade because:

• EE is sold inside combination products with different pricing dynamics
• realized price depends on progestin partner, regimen schedule, route, and brand status
• most EE exposure is in generics where ingredient-level margins are not public and vary by market

Decision-grade alternative: project at the level of combined products that include EE and trend with:

• prescription volume (users and prescriptions per year)
• mix shift (extended cycle, lower-dose, route mix)
• price index by geography and brand share

This is how investors and product planners usually underwrite EE-related exposures:

• track COC/combination estrogen demand by region
• map mix changes by regimen schedule and route
• apply gross margin bands based on branded vs generic share
• run sensitivity on formulary and competitive intensity

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What product-level strategies have the strongest commercialization fit for EE?

High-probability strategies are those that create “regimen value” without requiring EE molecule re-invention.

Most credible commercialization levers (in practice):

• Extended-cycle or simplified dosing schedules that improve bleeding control and adherence.
• Route optimization where supported by clinical evidence and payer preferences.
• Fixed-dose combinations with progestin partners that match guideline positions for specific patient subgroups.
• Life-cycle management through reformulation and regimen refinements to maintain differentiation while primary EE molecule remains generic.

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Key Takeaways

• Clinical development for EE is dominated by combination regimens and delivery systems, with endpoints focused on endocrine control, bleeding patterns, and tolerability rather than on novel EE biology.
• EE is structurally commoditized, so market outcomes hinge on regimen-level differentiation, payer contracting, and progestin partner selection.
• Market projections should be modeled around combined products containing EE, using prescription volume, mix shift (extended-cycle/route), and price erosion from generic competition rather than forecasting EE-only demand.
• Investment-grade upside is concentrated in product lifecycle strategies, not in new EE monotherapy innovation.

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FAQs

1) Is there meaningful late-stage development of Ethinyl Estradiol as a standalone molecule?

Most visible clinical activity is in combination and regimen-specific evaluations rather than EE monotherapy programs.

2) What drives demand for EE in practice?

Demand is driven by contraception regimen prescribing, adherence, cycle control needs, and formulary inclusion across COCs and related combination products.

3) Why does generic competition matter so much for EE?

Because EE and many fixed-dose combinations are broadly off-patent in many jurisdictions, pricing compresses and differentiation must come from secondary IP and regimen advantages.

4) What clinical endpoints most often define EE regimen success?

Companies typically pursue results on ovulation suppression/estrogenic control, bleeding pattern outcomes, and tolerability/safety.

5) How do investors typically underwrite EE-related exposures?

They underwrite at the combined product level by region, tracking branded vs generic mix, prescription volume, and route/schedule shifts.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/