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NCT00461305COMPLETEDanonymous

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

Sponsor

Source record

Bayer

Phase

Source record

PHASE2

Modality

AI-normalized

small molecule

Target

AI-normalized

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Indication / condition

AI-normalized

Dysmenorrhea

Intervention

Source record

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Source & freshness

Source record

NCT ID

NCT00461305

Original source

ClinicalTrials.gov

Source last updated

Jan 24, 2013

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00461305

Title

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

Sponsor

Bayer

Status

COMPLETED

Phase

PHASE2

Condition raw

Dysmenorrhea

Condition normalized

Dysmenorrhea

Modality raw

endometriosis

Modality normalized

small molecule

Target raw

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Target normalized

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Interventions

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Public preview

Source record

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles) is a PHASE2 clinical asset sponsored by Bayer in Dysmenorrhea. SEO and diligence focus: DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles), endpoint relevance, enrollment feasibility, competitive positioning, readout timing and IP durability.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT00461305

Status

COMPLETED

Phase

PHASE2

Sponsor

Bayer

Executive brief

Investment-Ready Snapshot

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles) is a PHASE2 clinical asset sponsored by Bayer in Dysmenorrhea. SEO and diligence focus: DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles), endpoint relevance, enrollment feasibility, competitive positioning, readout timing and IP durability.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJan 24, 2013
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00461305

Indication

Dysmenorrhea

Modality

small molecule

Target

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Intervention

DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.