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Levonorgestrel/Ethinyl Estradiol

Phase 3

Contraception | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Feb 8, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment2,000

FDA Designations

No designations recorded

Clinical trial landscape

Levonorgestrel/Ethinyl Estradiol · 5 trials · 4 indications

Phase 3 4Phase 1 1
NCT00195559Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric DisorderPremenstrual Syndrome
COMPLETED526 Analytics
NCT00128934Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric DisorderMenstruation Disturbances
COMPLETED744 Analytics
NCT00161681Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMSPremenstrual Syndrome
COMPLETED200 Analytics
NCT00245921Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral ContraceptionContraception
COMPLETED2,000 Analytics
PHASE3COMPLETED
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Premenstrual SyndromeUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Menstruation DisturbancesUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Premenstrual SyndromeUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
To evaluate safety and contraceptive efficacy
Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Secondary Endpoints

Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo
To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Levonorgestrel/Ethinyl EstradiolDRUG -
Levonorgestrel 90 mg/Ethinyl Estradiol 20 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 49 Years
SexFEMALE
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Generally healthy, women aged 18 to 49 years. * History of severe PMS symptoms over the last year, as determined by the investigator. * Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: * Major depressive disorder requiring ant...

Countries:ArgentinaBrazilChileDenmarkFinlandGermanyMexicoNetherlandsPolandRomaniaSwedenUnited KingdomUnited StatesCanada
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Frequently asked questions about Levonorgestrel/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.