deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT00461305

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

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

Conditions Dysmenorrhea
Updated 6 times since 2017 Last updated: Jan 22, 2013 Started: Feb 28, 2007 Primary completion: Jan 31, 2009 Completion: Aug 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Dysmenorrhea, this trial is completed. The trial is conducted by Bayer and has accumulated 6 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 9 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2_PHASE3

    First recorded

Feb 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .