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Hormone Therapy

1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet for Dysmenorrhea

Phase 2
Waitlist Available
Research Sponsored by Duramed Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13-week treatment period
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

Eligible Conditions
  • Dysmenorrhea
  • Menstrual Cramps

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13-week treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13-week treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in Average Severity for Abdominal/Pelvic Pain
Secondary study objectives
Analgesic Use
Abdomen

Side effects data

From 2008 Phase 2 trial • 95 Patients • NCT00196313
19%
Headache
19%
Nausea
13%
Sinusitis
11%
Nasopharyngitis
9%
Gastroenteritis Viral
9%
Abdominal Pain Upper
9%
Diarrhoea
6%
Vomiting
6%
Pharyngolaryngeal Pain
6%
Pharyngitis Streptococcal
2%
Excruciating pain rlated to menstruation
2%
Exacerbation of Stress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Seasonique

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletExperimental Treatment1 Intervention
Group II: 2Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levonorgestrel
FDA approved

Find a Location

Who is running the clinical trial?

Duramed ResearchLead Sponsor
24 Previous Clinical Trials
15,980 Total Patients Enrolled
1 Trials studying Dysmenorrhea
97 Patients Enrolled for Dysmenorrhea
~5 spots leftby Dec 2025
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