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Levonorgestrel

Phase 2

Ovulation | Small molecule | Other |Pfizer, Inc.|Last Updated: May 19, 2006

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Levonorgestrel · 1 trial · 1 indication

Phase 2 1
NCT00254189Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on OvulationOvulation
COMPLETED60 Analytics
PHASE2COMPLETED
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
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Study Endpoints

Primary Endpoints

To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.

Secondary Endpoints

To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
LevonorgestrelDRUG -
Ethinyl EstradiolDRUG -
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Eligibility Criteria

Age Range0 Years to 36 Years
SexFEMALE
Healthy VolunteersYes

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 pretreatm...

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Frequently asked questions about Levonorgestrel

What is Levonorgestrel used for?

Levonorgestrel is a small molecule drug being developed by Pfizer, Inc. for use as an oral contraceptive and for contraception. It is also studied for menstruation disturbances, premenstrual syndrome, ovulation, and in healthy volunteers. It is currently in clinical development and is not approved.

Who makes Levonorgestrel?

Levonorgestrel is developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is being studied in clinical trials for contraception and premenstrual syndrome, among other indications.

What phase is Levonorgestrel in?

Levonorgestrel is in Phase 2 of clinical development. It has completed two Phase 3 trials and one Phase 1 trial, with a total of two completed trials and no active trials. It is investigational and not yet approved.

What clinical trials is Levonorgestrel in?

Levonorgestrel has been studied in clinical trials including NCT00128934, NCT00161681, NCT00195559, and NCT00319163. These trials evaluated the drug for premenstrual dysphoric disorder, premenstrual syndrome, and healthy volunteers, with enrollment ranging from 26 to 744 participants.

Is Levonorgestrel the same as LNG/EE?

Levonorgestrel is often studied in combination with ethinyl estradiol, referred to as LNG/EE. Clinical trials such as NCT00128934 and NCT00161681 evaluate this combination for conditions like premenstrual dysphoric disorder and premenstrual syndrome.