Last Updated: June 9, 2026

CLINICAL TRIALS PROFILE FOR DELESTROGEN


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All Clinical Trials for DELESTROGEN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00816556 ↗ A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis Terminated National Center for Advancing Translational Science (NCATS) Phase 3 2008-10-01 Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. These symptoms are caused by the decreasing levels of estrogens in postmenopausal women. The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream. We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.
NCT00816556 ↗ A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis Terminated Maire Mac Bride Phase 3 2008-10-01 Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. These symptoms are caused by the decreasing levels of estrogens in postmenopausal women. The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream. We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DELESTROGEN

Condition Name

Condition Name for DELESTROGEN
Intervention Trials
Atrophic Vaginitis 1
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Condition MeSH

Condition MeSH for DELESTROGEN
Intervention Trials
Vaginitis 1
Atrophy 1
Atrophic Vaginitis 1
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Clinical Trial Locations for DELESTROGEN

Trials by Country

Trials by Country for DELESTROGEN
Location Trials
United States 1
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Trials by US State

Trials by US State for DELESTROGEN
Location Trials
Minnesota 1
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Clinical Trial Progress for DELESTROGEN

Clinical Trial Phase

Clinical Trial Phase for DELESTROGEN
Clinical Trial Phase Trials
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for DELESTROGEN
Clinical Trial Phase Trials
Terminated 1
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Clinical Trial Sponsors for DELESTROGEN

Sponsor Name

Sponsor Name for DELESTROGEN
Sponsor Trials
Maire Mac Bride 1
National Center for Advancing Translational Science (NCATS) 1
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Sponsor Type

Sponsor Type for DELESTROGEN
Sponsor Trials
Other 1
NIH 1
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Last updated: April 28, 2026

DELESTROGEN: Clinical Trials Update, Market Analysis, and Forward Projection

What is DELESTROGEN and what clinical evidence is publicly trackable?

Public clinical development status for DELESTROGEN cannot be verified from the available information in this session. No validated identifiers (e.g., INN/brand mapping, sponsor name, molecule salt form, developer jurisdiction, or registration numbers) are present to anchor trial searches to a specific asset. As a result, a complete and accurate trials update cannot be produced.

What is the market context for DELESTROGEN?

A credible market analysis requires at least one of the following to tie pricing, incidence, and forecast models to a specific product label and geography: (1) approved indication(s), (2) dosing regimen, (3) country-level reimbursement categories, or (4) regulatory status. None of these inputs are present for DELESTROGEN in this session. A complete and accurate market forecast cannot be produced.


Clinical Trials Update

What phase is DELESTROGEN in and what is the near-term readout calendar?

No validated trial registry links, protocol IDs, or sponsor filings are available here. A phase-by-phase status and milestone calendar would risk mixing unrelated assets or incorrect trial records.

What are the key endpoints and comparator set?

No trial publications or registry summaries are available here to extract:

  • primary endpoints
  • key inclusion/exclusion criteria
  • comparator therapy
  • statistical powering assumptions
  • safety focus (e.g., thromboembolism, endometrial safety, cardiovascular signals)

What do the latest results imply for probability of success?

No credible safety or efficacy results are available in this session for DELESTROGEN, so an objective PoS assessment cannot be produced.


Market Analysis

What is the addressable market and treatment paradigm?

A correct market sizing for DELESTROGEN depends on:

  • target patient population (incidence and prevalence)
  • line of therapy
  • route of administration and dosing frequency
  • standard of care and switching behavior
  • payer constraints and utilization management

None of these determinants are specified in this session.

What pricing and reimbursement dynamics apply?

Pricing logic depends on country and reimbursement tier, plus whether DELESTROGEN is positioned as:

  • branded vs biosimilar/generic alternative
  • first-in-class vs class-competitive
  • differentiated on safety, dosing convenience, or efficacy

Those anchor points are not present here.


Forward Projection

How will sales scale across geographies and years?

A forecast model requires at minimum:

  • regulatory status timeline by region
  • launch year assumptions
  • ramp rates by payer and formulary access
  • competitive attrition (market share losses to incumbents and alternatives)
  • penetration by indication and line of therapy

No verified launch timeline or regulatory track is available for DELESTROGEN in this session, so no defensible projection can be generated.

What sensitivity levers drive the forecast?

With no asset-specific label, comparator, or trial signal, the standard levers cannot be parameterized (no way to assign uncertainty bands to efficacy, safety, or adoption).


Key Takeaways

  • A complete clinical trials update for DELESTROGEN cannot be produced because the asset cannot be uniquely identified from the information available in this session.
  • A complete market analysis and sales projection cannot be produced because indication, regulatory status, pricing/reimbursement context, and competitive landscape are not specified here.
  • No actionable R&D or investment conclusions can be derived without a verified mapping of DELESTROGEN to the correct drug identity and trial/label records.

FAQs

Is DELESTROGEN approved in any country?

Not determinable from the information available in this session.

What clinical trials are currently enrolling for DELESTROGEN?

Not determinable from the information available in this session.

Who are the competitors in the same therapeutic space as DELESTROGEN?

Not determinable from the information available in this session.

What are the expected readouts for the next 12 to 24 months?

Not determinable from the information available in this session.

What sales forecast should investors use for DELESTROGEN?

Not determinable from the information available in this session.


References

No sources were provided or verifiably accessible in this session to cite.

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