Clinical trial with Nestorone™ subdermal contraceptive implants
| Autor: | Pekka Lähteenmäki, Alfred J. Moo-Young, Soledad Diaz, A. Brandeis, Ana Zepeda, Margarita Pavez, H.B. Croxatto, V. Schiappacasse |
|---|---|
| Rok vydání: | 1995 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent medicine.drug_class media_common.quotation_subject Population Urology Subdermal implant 03 medical and health sciences 0302 clinical medicine Contraceptive Agents Female Humans Medicine 030212 general & internal medicine education Ovulation Menstrual Cycle Progesterone media_common Drug Implants Pregnancy education.field_of_study 030219 obstetrics & reproductive medicine business.industry Ovary Obstetrics and Gynecology Silastic medicine.disease 3. Good health Surgery Clinical research Reproductive Medicine Female Implant business Progestin Norprogesterones |
| Zdroj: | Contraception. 51:33-38 |
| ISSN: | 0010-7824 |
| Popis: | The clinical performance and the in vivo release rate of a single 4-cm Nestorone subdermal implant were investigated. Implants manufactured by two different procedures were compared. Volunteers were 70 healthy women of proven fertility. Forty women provided blood samples twice a week in the pretreatment cycle and for 5-6 weeks at 6-month intervals during treatment. Additional control cycles (n = 31) were studied in 19 Copper T users. No pregnancy occurred in 1570 woman-months. Nestorone plasma levels (x +/- S.E.) declined from 112 +/- 8 to 86 +/- 3 pmol/L (Implant A) and from 145 +/- 8 to 57 +/- 5 pmol/L (Implant B) from the first to the 24th month. Progesterone levels were9.5 nmol/L in 166 (93%) of 178 blood samplings taken during treatment. Progesterone levels16 nmol/L were found in only 7 sampling periods (3.9%) in treated women and in 70 (98.6%) out of 71 control cycles. No ovulation occurred with Nestorone plasma levels above 105 pmol/L. No abnormal changes were observed in plasma lipoproteins or other clinical chemistry parameters during treatment. The implants were well tolerated. The most frequent complaint was the occurrence of irregular bleeding. Enlarged follicles found during pelvic examination in 8 subjects (11.4%) disappeared spontaneously in 10 days to 6 weeks. Implants were removed because of medical (n = 10, 14.3%) or personal reasons (n = 6, 8.6%) or at the 24th month of treatment (n = 54, 77.1%). The estimated average daily in vivo release rate of Nestorone was 45-50 micrograms/day. A single Nestorone subdermal implant affords efficient contraceptive protection during two years. |
| Databáze: | OpenAIRE |
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