Contraception
Conditions
Keywords
pregnancy prevention, oral contraceptives
Brief summary
This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
Detailed description
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.
Interventions
DRUGDR-1021
1 tablet daily
Sponsors
Duramed Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Premenopausal * Not pregnant or breastfeeding * Sexually active at risk of pregnancy
Exclusion criteria
* Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of pregnancy rates | Duration of study |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported by patients and investigators | Duration of study |
Countries
United States
Outcome results
None listed