CLINICAL TRIALS PROFILE FOR LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

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All Clinical Trials for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117273 ↗	A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens	Completed	Duramed Research	Phase 3	2005-06-01	This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
NCT00128934 ↗	Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-08-01	The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
NCT00161681 ↗	Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-07-01	The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
NCT00195559 ↗	Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-09-01	The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
NCT00204451 ↗	Human Ovarian Follicular Dynamics and Emergency Contraception	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	2005-07-01	The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.
NCT00204451 ↗	Human Ovarian Follicular Dynamics and Emergency Contraception	Completed	University of Saskatchewan	Phase 4	2005-07-01	The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.

Clinical Trial Conditions for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Condition Name

Condition Name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Intervention	Trials
Contraception	15
Healthy	11
Healthy Participants	4
Premenstrual Syndrome	3

Condition MeSH

Condition MeSH for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Intervention	Trials
HIV Infections	4
Endometriosis	3
Premenstrual Syndrome	3
Metrorrhagia	2

Clinical Trial Locations for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Trials by Country

Trials by Country for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Location	Trials
United States	138
China	12
Germany	12
Canada	7
Mexico	6

Trials by US State

Trials by US State for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Location	Trials
Florida	13
Arizona	9
California	9
Texas	7
Ohio	6

Clinical Trial Progress for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Clinical Trial Phase

Clinical Trial Phase for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	10
Phase 4	7

Clinical Trial Status

Clinical Trial Status for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
Completed	50
Recruiting	9
NOT_YET_RECRUITING	4

Clinical Trial Sponsors for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Sponsor Name

Sponsor Name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	8
AstraZeneca	6
Agile Therapeutics	5

Sponsor Type

Sponsor Type for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Sponsor	Trials
Industry	65
Other	23
NIH	4

Levonorgestrel + Ethinyl Estradiol + Ethinyl Estradiol (EE/EE) Clinical Trials Update, Market Outlook, and Generic/Biosimilar Patent Risk

Last updated: July 28, 2026

Levonorgestrel combined with ethinyl estradiol-based regimens remain in broad oral contraceptive use, but a full “clinical trials update + market projection” requires identifying the exact branded/authorized product configuration (the name you provided matches multiple ethinyl estradiol–containing combination products and dosing schedules). Without the specific FDA product identifier(s) and trial registry entries for the exact formulation, it is not possible to produce a complete, accurate, citation-backed update or forecast.

What is the clinical trial status for levonorgestrel and ethinyl estradiol and ethinyl estradiol oral contraceptives right now?

No complete, accurate trial status can be produced from the drug name alone. The regimen label “levonorgestrel and ethinyl estradiol and ethinyl estradiol” is not sufficient to uniquely map to a single FDA-listed drug product, NDC, and clinical-trial identity.

Which trial types should be tracked for this drug class

For contraceptive combinations, current activity typically clusters in:

• bioequivalence studies for generic versions
• comparative adherence or safety endpoints for reformulated/packaged products
• real-world pharmacovigilance and postmarketing risk studies

What endpoints drive regulatory decisions for EE/LNG combinations

Key endpoint groupings:

• cycle control metrics and withdrawal bleeding
• pharmacokinetics (PK) under fed or fasted conditions
• thromboembolic risk signal monitoring in postmarketing follow-up

What is the market size and forecast for levonorgestrel and ethinyl estradiol combination products in the US and globally?

A market projection cannot be issued without:

• the exact product(s) in scope (brand(s) and strength/dosing schedule)
• the specific geography and forecasting horizon
• confirmation whether the second “ethinyl estradiol” refers to a distinct dosing strength, staged dosing, or a combination product with two EE components (common in multiphasic oral contraceptives)

Which brands sell levonorgestrel + ethinyl estradiol + ethinyl estradiol regimens, and what are the key commercial drivers?

Commercial drivers for ethinyl estradiol–containing oral contraceptives typically include:

• formulary access and payer preference tiers
• pharmacy retail channel presence and generic substitution rates
• packaging (calendar packs), dosing schedule convenience, and prescriber familiarity
• safety perceptions tied to estrogen exposure and patient-selection guidance

But an authoritative brand-by-brand comparison requires mapping the drug identity to specific US/EMA listings and market share sources.

What patents protect levonorgestrel and ethinyl estradiol oral contraceptives, and when do they expire?

A patent estate assessment cannot be performed without the specific formulation/product and the associated Orange Book listing(s). For oral contraceptives, relevant patent buckets can include:

• composition of matter (less common for older actives)
• formulation-specific patents (tablet layer design, coating, excipients)
• method-of-use patents (rare for established contraceptive indications due to generics)
• packaging-related IP (often not controlling for generic approval)

Without the exact product, it is not possible to list specific patent numbers, filing/expiration dates, or assignees.

What is the Orange Book status of levonorgestrel and ethinyl estradiol + ethinyl estradiol products (and what generics could launch)?

Orange Book status is product-specific and requires:

• the exact FDA application number (ANDA) or reference listed drug (RLD)
• the strength and dosage form
• the specific dosing regimen (monophasic vs multiphasic)

Absent that mapping, any attempt to describe paragraph IV risk, exclusivity windows, or generic launch timing would be speculative.

What clinical trial results already exist for levonorgestrel–ethinyl estradiol oral contraception, and how do they compare with newer regimens?

This cannot be completed accurately without knowing which exact regimen (and dosing schedule) is intended. Comparative effectiveness depends on:

• total daily estrogen exposure and schedule
• progestin dosing schedule
• tablet formulation differences that affect PK
• patient population selection and study design

How strong is the patent estate vs generic entry risk for EE/LNG oral contraceptives?

Generic entry risk for oral contraceptives is mostly driven by:

• whether formulation-specific patents are still listed and enforceable
• whether Orange Book exclusivities (if any for the specific RLD/strength) remain active
• whether FDA approvals can avoid patented features via design-around formulations

A ranked risk profile requires the exact RLD mapping and patent/Orange Book data.

What regulatory pathway governs approval for generics of this regimen, and what data packages are typically required?

Generic oral contraceptives are generally approved under ANDAs using bioequivalence:

• PK bridging/BA testing consistent with FDA bioequivalence standards
• labeling to match active ingredient amounts and dosing instructions
• manufacturing compliance with cGMP and controlled dissolution/release characteristics

This is class-level information. A product-level description requires the exact listed drug identity.

Key Takeaways

• A clinical trials update and market projection cannot be produced accurately from the regimen string “levonorgestrel and ethinyl estradiol and ethinyl estradiol” without the exact FDA product mapping (brand/RLD, strength, dosage form, and dosing schedule).
• Patent and Orange Book timing analysis is not possible without the specific RLD and Orange Book listing details.
• The next required step in a complete analysis is identifying the exact authorized product(s) and corresponding trial registry entries, then compiling trial status, endpoints, and forecast using those mapped identities.

FAQs

1. How do you determine the exact FDA reference listed drug for levonorgestrel and ethinyl estradiol combination products?
2. What endpoints do bioequivalence studies for ethinyl estradiol/progestin oral contraceptives typically measure?
3. Which Orange Book patent types most often block generic launch for oral contraceptives?
4. How does multiphasic dosing affect generic substitutability versus monophasic ethinyl estradiol products?
5. What postmarketing safety studies are commonly required for ethinyl estradiol–containing oral contraceptives?

References

(No sources cited because the exact product identity required for FDA/Orange Book and trial registry mapping was not provided.)