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Effect on Primary Dysmenorrhea

NCT00909857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2015-08-24

Study results available
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Summary

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Conditions

  • Primary Dysmenorrhea

Interventions

DRUG

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval

DRUG

Ethinyl estradiol, Levonorgestrel (Miranova)

Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

DRUG

Placebo Match to SH T00658ID

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

DRUG

Placebo Match to SH D593B

Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Canada
  • Chile
  • Germany
  • Italy
  • Philippines

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909857 on ClinicalTrials.gov