Extended use of a progesterone-releasing vaginal ring in nursing women: a phase II clinical trial

Massai, Rebeca; Quinteros, Eliana; Reyes, María Verónica; Caviedes, Roxana; Zepeda, Ana; Montero, Juan Carlos; Croxatto, Horacio B.

doi:10.1016/j.contraception.2005.05.004

Cited by 26 publications

(13 citation statements)

References 13 publications

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“…In a large trial with lactating women using the 10-mg/day P-only ring, the pregnancy rate at the end of 1 year was 1.5/100 women63 and 46% of the continuers remained in amenorrhea. Another study assessed extended use of the ring in 192 users for 4 months (instead of 3 months), concluding that it was safe and effective as a contraceptive for nursing women over this period of time 64. Further studies are currently being conducted in 20 centers in India 65…”

Section: New Contraceptive Methods Recently Launched In Different Marmentioning

confidence: 99%

New and emerging contraceptives: a state-of-the-art review

Bahamondes¹,

Bahamondes²

2014

IJWH

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BackgroundThe first hormonal contraceptive was introduced onto the market in several countries 50 years ago; however, the portfolio of contraceptive methods remains restricted with regards to their steroid composition, their cost, and their ability to satisfy the requirements of millions of women/couples in accordance with their different reproductive intentions, behaviors, cultures, and settings.MethodsA literature review was conducted using Medline, Embase, and Current Contents databases, up to September 1, 2013 to identify publications reporting new contraceptives in development using combinations of the search terms: contraception, contraceptives, oral contraceptives, patch, vaginal ring, implants, intrauterine contraceptives, and emergency contraception (EC). Also, several experts in the field were also consulted to document ongoing projects on contraception development. Additionally, the Clinicaltrial.gov website was searched for ongoing studies on existing contraceptive methods and new and emerging female contraceptives developed over the past 5 years. Information was also obtained from the pharmaceutical industry.ResultsEarly sexual debut and late menopause means that women may require contraception for up to 30 years. Although oral, injectable, vaginal, transdermal, subdermal, and intrauterine contraceptives are already available, new contraceptives have been developed in an attempt to reduce side effects and avoid early discontinuation, and to fulfill women’s different requirements. Research efforts are focused on replacing ethinyl-estradiol with natural estradiol to reduce thrombotic events. In addition, new, less androgenic progestins are being introduced and selective progesterone receptor modulators and new delivery systems are being used. In addition, research is being conducted into methods that offer dual protection (contraception and protection against human immunodeficiency virus transmission), and contraceptives for use “on demand.” Studies are also investigating non-hormonal contraceptive methods that have additional, non-contraceptive benefits.ConclusionThe most pressing need worldwide is, first, that the highly effective contraceptive methods already available should be affordable to most of the population and also that these methods should fulfill the needs of women of different ages and with different reproductive requirements. The development of new contraceptive methods should also take advantage of the knowledge obtained over the past 30 years on gamete physiology and gamete interaction to avoid the use of steroid compounds.

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Section: New Contraceptive Methods Recently Launched In Different Marmentioning

confidence: 99%

New and emerging contraceptives: a state-of-the-art review

Bahamondes¹,

Bahamondes²

2014

IJWH

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“…4. The effectiveness of Progering in users during breast feeding demonstrated the safety and efficacy of this IVR product [20,21].…”

Section: Contraceptive Ivrsmentioning

confidence: 97%

“…The ring is designed to release progesterone at a daily rate of 10 mg [20]. This rate is relatively high compared with most drugs released from IVRs.…”

Section: Contraceptive Ivrsmentioning

confidence: 99%

Intravaginal rings: controlled release systems for contraception and prevention of transmission of sexually transmitted infections

Friend

2011

Drug Deliv. and Transl. Res.

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Intravaginal rings (IVRs) are a dosage form used to locally or systemically deliver drugs in the vagina. They are capable of releasing one or more drugs over an extended period of time (from several weeks to a year or longer). Contraceptive IVRs are currently gaining popularity due to the success of the contraceptive product NuvaRing®. Delivery of contraceptives from IVRs should promote compliance/adherence, and they also provide effective cycle control and symptom relief (menorrhagia, dysmenorrheal, and polycystic ovarian syndrome). Vaginal delivery of proteins from IVRs was first explored in an attempt to deliver IgG2a antibody intravaginally to neutralize herpes simplex virus 2. More recently, IVRs capable of releasing antibodies and recombinant proteins potentially along with low molecular weight microbicides are under investigation for prevention of HIV-1 transmission. Vaginal delivery of microbicides has been studied with several drugs most notably the non-nucleoside reverse transcriptase inhibitor dapivirine. Another drug capable of blocking transmission of HIV-1 when released from IVRs is tenofovir. Finally, combinations of drugs with different indications (i.e., multipurpose prevention technologies) are actively being pursued.

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“…In a phase 2 clinical trial that assessed extending use of the PVR to 4 months, mean P levels decreased from 17±1 to 14±1 nmol/L (mean± S.E. ), still within the range to inhibit ovulation [10]. With regard to infant exposure to P via the breast milk of mothers who use the PVR, ingestion of 600 mL of breast milk per day will expose infants to approximately 4.2 mcg of P [11,12].…”

Section: Introductionmentioning

confidence: 98%