A randomized crossover study to evaluate local tolerability following subcutaneous administration of a new depot medroxyprogesterone acetate contraceptive formulation.

Objectives: This study aimed to evaluate and compare local tolerability of investigational drug TV-46046 and reference drug Depo-subQ Provera 104, both containing medroxyprogesterone acetate (MPA) as an active ingredient.

Study Design: We conducted a randomized, crossover, single-center study. Twenty-seven healthy women aged 25 to 47 years at low risk of pregnancy received a subcutaneous injection of each of the four study drugs (120 mg/0.

Return to ovulation after Sayana Press is injected every 4 months for one year: Empirical and pharmacokinetic/pharmacodynamic modeling results.

Objective: To characterize return to ovulation after injecting Sayana Press (104 mg/0.65 mL medroxyprogesterone acetate [MPA] in the Uniject device) every 4 months for 1 year of treatment.

Study Design: We followed a subset of women for return to ovulation in a trial that demonstrated Sayana Press remains highly effective when the subcutaneous reinjection interval is extended from 3 to 4 months.

Ovulation suppression following subcutaneous administration of depot medroxyprogesterone acetate.

Objectives: To characterize the relationship between serum medroxyprogesterone acetate (MPA) concentrations and ovulation suppression, and to estimate the risk of ovulation for investigational subcutaneous regimens of Depo-Provera CI (Depo-Provera) and Depo-subQ Provera 104 (Depo-subQ).

Study Design: We performed a secondary analysis of 2 studies that assessed the pharmacokinetics and pharmacodynamics of MPA when Depo-Provera is administered subcutaneously rather than by the labeled intramuscular route. Each woman received a single 45 mg to 300 mg subcutaneous injection of Depo-Provera, a single 104 mg subcutaneous injection of Depo-subQ, or 2 injections of Depo-subQ at 3-month intervals.

Contraceptive effectiveness, pharmacokinetics, and safety of Sayana® Press when injected every four months: a multicenter phase 3 trial.

Background: Sayana Press® is a 3-monthly contraceptive injection approved by regulatory agencies in more than 40 countries worldwide. Existing effectiveness and pharmacokinetics (PK) data suggest that high contraceptive efficacy may be maintained if the reinjection interval of Sayana Press is extended from 3 to 4 months.

Methods: We conducted a phase 3 trial at three sites in the Dominican Republic, Brazil, and Chile from September 2017 through April 2020.

Suppression of ovulation and pharmacokinetics following subcutaneous administration of various doses of Depo-Provera®: a randomized trial.

Objectives: To identify the lowest dose of Depo-Provera that, when administered off-label subcutaneously, suppressed ovulation and had a pharmacokinetic profile consistent with a 4-month contraceptive effect.

Study Design: We conducted a randomized, multicenter, parallel-group study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of medroxyprogesterone acetate (MPA) after subcutaneous injection of three different doses of Depo-Provera. We randomized sixty women between 18 and 40 years of age at low risk of pregnancy with confirmed ovulation and body mass index of 18 to 35 kg/m to receive a single injection of 45, 75 or 105 mg of Depo-Provera, or a single injection of Depo-subQ provera 104 as a reference drug (15 women per group) and followed them for 7.

Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera.

Objective: To evaluate the pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after a single subcutaneous injection in the abdomen of 150 or 300 mg Depo-Provera and compare results to two injections of Depo-SubQ Provera 104 given 3 months apart.

Design: Partially randomized, multicenter, parallel-group study.

Setting: Research unit.

Injectable contraception: updates and innovation.

Purpose Of Review: Injectable contraception is a highly effective form of birth control that is globally popular. Recent research has focused on ways to make injectables such as depot medroxyprogesterone acetate (DMPA) more accessible and to improve the side-effect profile of injectables. This review will focus on new directions and approaches to the use of injectable contraception.

Ectopic pregnancy with use of progestin-only injectables and contraceptive implants: a systematic review.

Background: Use of contraception lowers a woman's risk of experiencing an ectopic pregnancy. In the case of method failure, however, progestin-only contraceptives may be more likely to result in ectopic pregnancies than some other methods such as combined hormonal and barrier contraceptives.

Objective: To describe ectopic pregnancy risk associated with use of implants and progestin-only injectable contraceptives through a systematic review of published studies.

Towards the development of a longer-acting injectable contraceptive: past research and current trends.

Objectives: A longer-acting injectable contraceptive that lasts for 6 months would be a valuable addition to the contraceptive method mix and ideal for women who are interested in spacing births and/or uncertain about their future reproductive plans. Here we review past applications of drug delivery technologies to injectable contraceptives as well as recent advancements in sustained drug delivery technologies that hold promise for the development of a new longer-acting injectable contraceptive product.

Study Design: A global landscape analysis was conducted, promising sustained drug delivery technologies, and research opportunities and partnerships were established with experts in the fields of contraception and drug delivery to identify new approaches in developing a longer-acting injectable contraceptive product.

Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy.

Background: Repeated use of postcoital hormonal contraception is not currently recommended due to the higher risk of side effects and lower contraceptive effectiveness compared to other modern methods of contraception. However, emerging evidence indicates renewed interest in a regular coitally-dependent method of oral contraception. We evaluated the existing data on safety and effectiveness of pericoital use of levonorgestrel and other hormonal drugs to prevent pregnancy.

A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

Background: An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception.

Spermicide used alone for contraception.

Background: Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository.

Strategies to improve adherence and acceptability of hormonal methods of contraception.

Background: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. In large part, this disparity reflects difficulties in adherence to the contraceptive regimen and low rates for long-term continuation.

Spermicide used alone for contraception.

Background: Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository.

Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm.

Background: The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104™. We evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper arm, a preferred injection site in developing countries.

Study Design: Twenty-six women in Norfolk, VA, received a single injection of Depo-SubQ Provera 104 in the upper arm in this prospective noncomparative study.

Steroid hormones for contraception in men.

Background: Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so 'add-back' therapy is needed.

Pelvic surgery and hospitalization among Chilean women after nonsurgical sterilization with quinacrine pellets between 1977 and 1989.

Background: Concern about quinacrine lingers because of its carcinogenic effects in rats. We describe results of long-term follow-up of women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N=1492).

Methods: We interviewed the women or relatives in five rounds of data collection between 1991-1993 and 2006-2007, and reviewed hospital records.

Strategies to improve adherence and acceptability of hormonal methods of contraception.

Background: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives in current use. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. In large part, this disparity reflects difficulties in adherence to the contraceptive regimen and low rates for long-term continuation.

Predictors of pregnancy in microbicide trials.

Background: High pregnancy rates undermine the conduct and interpretation of HIV prevention trials. We performed this analysis to identify baseline participant characteristics associated with increased risk of pregnancy in recent vaginal microbicide trials.

Study Design: We analyzed the data from four recently completed Phase III trials of candidate microbicides for prevention of HIV infection.

Pericoital oral contraception with levonorgestrel: a systematic review.

Objective: To determine the effectiveness and safety of repeated precoital and postcoital use of levonorgestrel for pregnancy prevention.

Data Sources: We searched eight computerized databases for studies that evaluated oral hormones taken for contraception immediately before or after each coital act during one or more menstrual cycles. We reviewed reference lists and contacted experts.

Notes on the frequency of routinely collected and self-reported behavioral data in HIV prevention trials.

HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up.

Baseline factors associated with incident HIV and STI in four microbicide trials.

Background: Analyzing pooled data from 4 recent microbicide trials, we aimed to determine characteristics of participants at higher risk of HIV and sexually transmitted infections (STIs), to inform targeted recruitment, preserved study power, and potentially smaller study sizes in future trials.

Methods: We evaluated the relationships between participants' characteristics and the incidence of HIV, STIs, and reproductive tract infections (RTIs). We calculated incidence rates as the number of infection events divided by the person-years of observation.

Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy.

Background: Repeated use of postcoital hormonal contraception is not currently recommended due to the higher risk of side effects and lower contraceptive effectiveness compared to other modern methods of contraception. However, emerging evidence indicates renewed interest in a regular coitally-dependent method of oral contraception. We re-evaluated the existing data on safety and effectiveness of pericoital use of levonorgestrel and other hormonal drugs to prevent pregnancy.