Recent Updates
Recently added Catalysts

Hormonal Contraception

Phase 3

Pregnancy | Small molecule | Infectious Disease |United Therapeutics Corporation|Last Updated: Mar 6, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Hormonal Contraception · 1 trial · 2 indications

Phase 3 1
NCT00336245A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in ZambiaPregnancy
COMPLETED600 Analytics
PHASE3COMPLETED
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
PregnancyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incident pregnancy

Secondary Endpoints

Safety
Method discontinuation rates
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Copper T Intrauterine Contraceptive DeviceEXPERIMENTAL -
Hormonal ContraceptionACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Copper T Intrauterine Contraceptive DeviceDEVICE -
Hormonal ContraceptionDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range16 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * desire for at least 2 years of continuous contraception * two or fewer sexual partners in the prior year Exclusion Criteria: * advanced HIV disease (WHO Stage III or IV) * history of a bleeding disorder * history of PID within the prior five years * less than 16 years of age...

Unlock Eligibility Criteria

Frequently asked questions about Hormonal Contraception

What is Hormonal Contraception used for?

Hormonal Contraception is used for pregnancy prevention. It is being studied in a Phase 3 clinical trial in HIV-infected women in Zambia, where it is compared with an intrauterine device (IUD) for contraceptive efficacy. The trial enrolled 600 female participants aged 16 years and older.

Who makes Hormonal Contraception?

Hormonal Contraception is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 3 clinical trial of this small molecule contraceptive in HIV-infected women.

What phase is Hormonal Contraception in?

Hormonal Contraception is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial, NCT00336245, has been completed and enrolled 600 participants.

What clinical trials is Hormonal Contraception in?

Hormonal Contraception is associated with one completed Phase 3 clinical trial, NCT00336245, titled 'A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia.' The trial was active-controlled, randomized, and enrolled 600 female participants with HIV infection.

Is Hormonal Contraception the same as an IUD?

No, Hormonal Contraception is not the same as an IUD. In the clinical trial NCT00336245, hormonal contraception is compared against an intrauterine device (IUD) as an active control. The two are different contraceptive methods being evaluated for their effectiveness in preventing pregnancy.