POPLINE Document Number: 194567
Author(s):
Jain J
Dutton C
Nicosia A
Wajszczuk C
Bode FR
Source citation:
Contraception, 2004 Jul;70(1):11-18.
Abstract:
Depo-Provera is a highly effective contraceptive, given intramuscularly (150 mg/mL) once every 3 months. It has been in use in the United States for over 10 years. A new lower-dose formulation of Depo-Provera (104 mg/0.65 mL), has been developed that allows subcutaneous injection, potentially increasing the convenience, ease of administration and tolerability of this contraceptive. This prospective, randomized, single-center, single-dose trial evaluates the pharmacokinetics of the lower-dose formulation of Depo-Provera and compares the lower-dose formulation to the original formulation with regard to efficacy and duration of ovulation suppression and the return to ovulation at 12 months. While delivering a 30% lower total dose than the intramuscular formulation, the lower-dose formulation of Depo-Provera suppressed ovulation for more than 13 weeks in all subjects and was not affected by body mass index or race. Median time for return to ovulation was 30 weeks, with a 97.4% cumulative rate of return to ovulation at 12 months. (author's)
Keywords:
United StatesIndex page
Research Report
Clinical Trials
Women
Population Characteristics
Contraception
Depo-Provera
Injectables
Use-Effectiveness
Ovulation Suppression
Developed Countries
North America
Americas
Clinical Research
Research Methodology
Demographic Factors
Population
Family Planning
Medroxyprogesterone Acetate
Contraceptive Agents, Progestin
Contraceptive Agents, Female
Contraceptive Agents
Contraceptive Methods
Contraceptive Effectiveness
Contraceptive Mode of Action