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28-day drospirenone contraceptive

Phase 1

Follicle Development | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Dec 8, 2021

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

28-day drospirenone contraceptive · 1 trial · 5 indications

Phase 1 1
NCT01291004A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral ContraceptivesFollicle Development
COMPLETED206 Analytics
PHASE1COMPLETED
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
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Study Endpoints

Primary Endpoints

Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
16 weeks
Change in serum Estradiol level from baseline to week 16.
16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
16 weeks
Change in serum Progesterone level from baseline to week 20.
20 weeks

Secondary Endpoints

Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.
15 weeks
Change from baseline to week 15 in D-dimer.
15 weeks
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex
15 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
28-day Desogestrel Oral ContraceptiveEXPERIMENTAL -
28-day Drospirenone Oral ContraceptiveACTIVE_COMPARATOR -
28-day Levonorgestrel Oral ContraceptiveACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Desogestrel/ethinyl estradiol and ethinyl estradiolDRUGDesogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
28-day drospirenone oral contraceptiveDRUGDrospirenone/ethinyl estradiol 0.3/0.02 mg
28-day levonorgestrel oral contraceptiveDRUGLevonorgestrel/ethinyl estradiol 0.1/0.02 mg
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-35 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by Food and Drug Administration (FDA)-approved protocol Exclusion Criteria: * Any condition which ...

Countries:United States
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Frequently asked questions about 28-day drospirenone contraceptive

What is 28-day drospirenone contraceptive used for?

28-day drospirenone contraceptive is an investigational small molecule being studied for its effects on follicle development. It is being evaluated in a clinical trial for ovarian follicular activity, follicle count, and follicle size in healthy female volunteers. The drug is in Phase 1 clinical development and is not yet approved.

Who makes 28-day drospirenone contraceptive?

28-day drospirenone contraceptive is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical research on this investigational oral contraceptive.

What phase is 28-day drospirenone contraceptive in?

28-day drospirenone contraceptive is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is 28-day drospirenone contraceptive in?

28-day drospirenone contraceptive was studied in a completed Phase 1 trial with NCT number NCT01291004. The trial evaluated ovarian follicular activity and hormone levels compared to two 28-day oral contraceptives, enrolling 206 healthy female participants in the United States.

Is 28-day drospirenone contraceptive the same as DR-102?

Yes, 28-day drospirenone contraceptive is also known as DR-102. The clinical trial NCT01291004 refers to the drug as DR-102 when comparing it to two other 28-day oral contraceptives.