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Ethinyl estradiol, Levonorgestrel

Phase 3

Primary Dysmenorrhea | Small molecule | Other |Bayer AG|Last Updated: Aug 24, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment507

FDA Designations

No designations recorded

Clinical trial landscape

Ethinyl estradiol, Levonorgestrel · 1 trial · 1 indication

Phase 3 1
NCT00909857Effect on Primary DysmenorrheaPrimary Dysmenorrhea
COMPLETED507 Analytics
PHASE3COMPLETED
Effect on Primary Dysmenorrhea
Primary Dysmenorrhea
NCT00909857507
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Study Endpoints

Primary Endpoints

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

Secondary Endpoints

Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)EXPERIMENTALDaily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Ethinyl estradiol, Levonorgestrel (Miranova)ACTIVE_COMPARATORDaily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Interventions

NameTypeDescription
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)DRUGDaily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Ethinyl estradiol, Levonorgestrel (Miranova)DRUGDaily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Placebo Match to SH T00658IDDRUGDaily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Placebo Match to SH D593BDRUGDaily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
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Eligibility Criteria

Age Range14 Years to 50 Years
SexFEMALE
Healthy VolunteersYes
Study Sites41

Inclusion Criteria: * Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score * Age: 14 - 50 years (inclusive; smokers ...

Countries:United StatesCanadaChileGermanyItalyPhilippines
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Frequently asked questions about Ethinyl estradiol, Levonorgestrel

What is Ethinyl estradiol, Levonorgestrel used for?

Ethinyl estradiol, Levonorgestrel is a combination of two hormones used for contraception and for the treatment of primary dysmenorrhea. It is being developed by Bayer AG as a small molecule drug and is currently in Phase 3 clinical trials for these indications.

Who makes Ethinyl estradiol, Levonorgestrel?

Bayer AG, traded as BAYRY, is developing Ethinyl estradiol, Levonorgestrel. The drug is a small molecule combination product being studied for contraception and primary dysmenorrhea. It has completed four clinical trials with a total enrollment of 2,067 participants.

What phase is Ethinyl estradiol, Levonorgestrel in?

Ethinyl estradiol, Levonorgestrel is in Phase 3 clinical development. The Phase 3 trial, NCT00909857, studied its effect on primary dysmenorrhea and enrolled 507 participants. The drug is investigational and not yet approved for any indication.

What clinical trials is Ethinyl estradiol, Levonorgestrel in?

Ethinyl estradiol, Levonorgestrel has completed four clinical trials. NCT00873483 studied ovulation inhibition in obese women, NCT00896571 examined endometrial effects, NCT00909857 evaluated primary dysmenorrhea, and NCT00915915 assessed ovulation inhibition and pharmacokinetics. All trials are completed, with none currently active.

Is Ethinyl estradiol, Levonorgestrel the same as a transdermal contraceptive patch?

Ethinyl estradiol, Levonorgestrel is being studied in a transdermal patch formulation. Clinical trials NCT00896571 and NCT00915915 evaluated transdermal delivery of ethinyl estradiol combined with other progestins. The drug is also being investigated for oral use in contraception and dysmenorrhea.

What does Ethinyl estradiol, Levonorgestrel target?

Ethinyl estradiol, Levonorgestrel combines an estrogen and a progestin to prevent ovulation and manage menstrual pain. It works by suppressing ovulation for contraception and by reducing prostaglandin-related cramping in primary dysmenorrhea. The drug is being studied in healthy female volunteers across multiple countries.