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A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

D

Duramed Research

Status and phase

Completed
Phase 2

Conditions

Dysmenorrhea

Treatments

Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Drug: Placebo tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196313
DR-PSE-306

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

Female

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sexually naïve and agree to abstain from sex during the study
  • Moderate to severe menstrual-related pelvic pain
  • Regular spontaneous menstrual cycles

Exclusion criteria

  • Any contraindication to the use of oral contraceptives
  • Treatment with an oral contraceptive within the previous 3 months
  • Previous treatment failure with an extended oral contraceptive regimen

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

95 participants in 2 patient groups, including a placebo group

1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
Experimental group
Treatment:
Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
2
Placebo Comparator group
Treatment:
Drug: Placebo tablet

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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