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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Last updated on November 18, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovulation
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-36
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy women of legal age of consent who are willing to use a combination OC.

- Subjects must be under the age of 36 at the time of enrollment (visit 3).

- Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period
preceding entry into the pretreatment observation cycle, excluding postabortal and
nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must
have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before
entry into the pretreatment observation cycle. The pretreatment observation cycle for
all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

A history or the presence of any of the following will prevent enrollment:

- Thrombophlebitis, thrombosis, or thromboembolic disorders.

- Deep vein thrombosis.

- Pulmonary embolism.

Other exclusions apply.

NCT00254189
Pfizer
Completed
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

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Descriptive Information
Brief Title  ICMJE Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Official Title  ICMJE A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.
Brief SummaryTo determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovulation
Intervention  ICMJE
  • Drug: Levonorgestrel
  • Drug: Ethinyl Estradiol
Study Arms  ICMJE Not Provided
Publications *Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 14, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women of legal age of consent who are willing to use a combination OC.
  • Subjects must be under the age of 36 at the time of enrollment (visit 3).
  • Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion Criteria:

A history or the presence of any of the following will prevent enrollment:

  • Thrombophlebitis, thrombosis, or thromboembolic disorders.
  • Deep vein thrombosis.
  • Pulmonary embolism.

Other exclusions apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE up to 36 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254189
Other Study ID Numbers  ICMJE 0858A2-208
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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