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Levonorgestrel and Ethinyl Estradiol

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Levonorgestrel and Ethinyl Estradiol · 1 trial · 1 indication

Phase 3 1
NCT00248963Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral ContraceptionOral Contraceptive
COMPLETED600 Analytics
PHASE3COMPLETED
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Oral Contraceptive
NCT00248963600
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Study Endpoints

Primary Endpoints

To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen

Secondary Endpoints

To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeECT

Interventions

NameTypeDescription
Levonorgestrel 90 mg and Ethinyl Estradiol 20 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 49 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception. * Women must be sexually active and at risk for becoming pregnant. * Women must have had regular (21- to 35- day) menstrual cycles for the 3-m...

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Frequently asked questions about Levonorgestrel and Ethinyl Estradiol

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.