Trial | NCT00196352  Report issue

Title

A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    320
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.
Study Started
May 31
2003
Primary Completion
Nov 30
2006
Study Completion
Nov 30
2006
Last Update
Apr 08
2014
Estimate

Drug Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

1 tablet daily

  • Other names: Seasonique

1 Experimental

Criteria 

Inclusion Criteria:

Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
No Results Posted