Completed PHASE3 INTERVENTIONAL 2-arm NCT00909857

Effect on Primary Dysmenorrhea

A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea

Sponsor: Bayer

Conditions Primary Dysmenorrhea

Interventions Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl estradiol, Levonorgestrel (Miranova) Placebo Match to SH D593B Placebo Match to SH T00658ID

Updated 7 times since 2017 Last updated: Aug 6, 2015 Started: Apr 30, 2009 Primary completion: Nov 30, 2010 Completion: Nov 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00909857, this PHASE3 trial focuses on Primary Dysmenorrhea and remains completed. Sponsored by Bayer, it has been updated 7 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Apr 2009

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 .

Study Locations

Bernburg, Germany , Bologna, Italy , Brescia, Italy , Cebu, Philippines , Cebu City, Philippines , Cologne, Germany , Davao City, Philippines , Essen, Germany , Francavilla Fontana, Italy , Freiburg im Breisgau, Germany and 30 more locations