PHASE III, OPEN, MULTICENTER, MULTINATIONAL STUDY OF MEDROXIPROGESTERONA ACETATE (AMP 20 MG) AND ESTRADIOL CIPIONATE (E2C 5 MG) INJECTABLE SUSPENSION ADMINISTERED SUBCUTANEOUS

Not Applicable

• Conditions: -Z309 Contraceptive management, unspecified; Contraceptive management, unspecified; Z309

• Registration Number: PER-074-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-11-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Sexually active women between the ages of 18 and 49 at risk of becoming pregnant and who want contraception.
• Must be willing to rely exclusively on Lunelle SC for contraception for at least 1 year.
• Subjects who use hormonal birth control must undergo the following wash program; During this period they must use a barrier contraceptive method (not an IUD) or not be sexually active
• Analysis of negative pregnancy in urine.
• Must have a documented history of menstruating on a regular basis (cycle length: 25 to 35 days) during the 3 months prior to entering the study. This includes patients who are in postpartum and post-abortion period.
• Show willingness to enter the study and comply with the specific procedures of the same.
• Show willingness and be able to return at prescribed intervals for follow-up visits.
• Evidence of a signed and dated informed consent document indicating that the patient (or her legally acceptable representative) was informed of all relevant aspects of the trial.

Exclusion Criteria

• Concomitant use of aminoglutethimide, carbamazepine, rifampicin, griseofulvin, hydantoins, barbiturates, oxazepam, GnRH agonists, St. John´s wort, or antibiotics of the ampicillin and tetracycline classes.
• Cervical cytology: Any abnormality in the epithelial cells as reported in the Bethesda System, with the exception of reactive and reparative changes, such as: atypical squamous cells of undetermined significance (ASCUS) in the last 6 months prior to entering the study.
• History of cancer, suspected, current or past, with the exception of the carcinoma insitu of the neck of the uterus treated, with subsequent normal pap smears for 12 months, and basal cell cancer of the skin.
• Presumed / undiagnosed pelvic disease.
• Use of IUDs or hormonal birth control methods other than the study medication during the treatment period.
• Current breastfeeding or breastfeeding within the last three months.
• Selection mammography results that suggest a malignant disease or require a follow-up of 6 months. Mammograms (within the last 12 months) are only required for subjects over 40 years of age.
• Women or their partners with a diagnosis of known infertility.
• Known or suspected pregnancy, or desire to achieve pregnancy during the study.
• Past or present thromboembolic disease, with the exception of superficial thrombophlebitis.
• Coronary artery disease or active cerebral vascular disease or history of having suffered such a disease.
• Unexplained abnormal genital bleeding.
• Antecedents (within the last five years) of alcohol abuse (more than 2 to 3 drinks per day) or other abuse of Medicines.
• Cholestatic jaundice of pregnancy, or a history of jaundice with previous use of hormonal contraception including severe pruritus of pregnancy.
• Current hypertension confirmed: defined as systolic blood pressure> 160 mmHg or diastolic> 90 mmHg. Stable hypertension is authorized under antihypertensive medication during the previous 6 months.
• Active pathology or history of clinically significant liver or kidney pathology. (Hepatopathology is defined as a level of AST / SGOT, ALT / SGPT, or GGPT 2.5 times the upper normal limit, and a total bilirubin level> 1.5 mg / dl, the renal is defined as a level of creatinine> 1.5 mg / dl).
• Hypersensitivity to study medications, or subjects in whom estrogen and / or progestin are contraindicated.
• Any subject unable to understand the necessary instructions, or who is reasonably expected to not complete the study.
• Concurrent use of other medications under investigation or their use in the previous 30 days.
• Previous participation in this study.
• Diabetes mellitus with vascular compromise.
• Headaches with focal neurological symptoms.
• Vascular cardiac pathology with complications.
• Women over 35 years old smokers (> 15 cigarettes / day).
• Other chronic medical condition, severe acute, or psychiatric, laboratory abnormality or consumption of another Medicine that may increase the risk associated with participation in the study or with the administration of study Medicine, or that may interfere with the interpretation of the results of the study, and that, according to the investigator´s criteria, it makes the subject inappropriate to enter the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified