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A multicenter, non-comparative trial on the contraceptive efficacy, safety and tolerability of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during 13 cycles Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability of LPRI-424, 13 Cycles

Study

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Description

? 9 visits over 13. 5 months ? Physical Exam, Pelvic Exam ? Trans-Vaginal Ultrasound, Blood draws ? Daily e-diary completion

Details
Age

Child to Adult

Eligibility

? Age: 13-40 years ? Sexually Active ? Not on hormonal Birth Control

Detailed Eligibility: 1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy aged between 13-45 years (inclusive). Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided that a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. 2. Womenwho a. have never used hormonal contraceptives before consent/assent (nai"ve users), b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or c. directly switch from another hormonal contraceptive (switchers). 3. Only for subjects who were not pregnant and did not use hormonal contraception during the last six months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months. 4. Only for women who were pregnant within the last six months before consent/assent: At least three complete menstrual cycles after pregnancy. 5. At screening, systolic blood pressure '.S 140 mm Hg and diastolic blood pressure '.S 90 mm Hg. 6. Be able and willing to provide written informed consent/assent prior to undergoing any trial-related procedure. 7. Willing to use trial contraception for thirteen 28-day cycles. 8. Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive. The use of condoms for prevention of sexually transmittable infections is allowed. 9. Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile. 10. Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Outcomes Research

Location

Comprehensive Women's Health Center

Principal Investigator
Stephanie Teal,  MD

Stephanie Teal, MD

Study ID

Protocol Number: 19-2895

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