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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Last updated on May 12, 2018

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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.
Show details

- 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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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
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.
To 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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovulation
  • Drug: Levonorgestrel
  • Drug: Ethinyl Estradiol
Not Provided
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.
 
Completed
60
October 2004
Not Provided

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.

Sexes Eligible for Study: Female
up to 36 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00254189
0858A2-208
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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