Phase I clinical trials with three formulations of anti-human chorionic gonadotropin vaccine.

Abstract:

:Comparative phase I clinical trials were carried out in 5 centres with three formulations of beta-hCG-based vaccines inducing antibodies against human chorionic gonadotropin. The objectives of these trials were to determine their relative immunogenicity, duration, reversibility and safety. A total of 116 tubal ligated women volunteers were enrolled in the study and 101 subjects were followed-up for one year or more until the antibody titres declined to near zero levels. Every woman receiving the vaccine produced anti-hCG and anti-tetanus antibodies. Clinical examination carried out at intervals of 4-6 weeks revealed no abnormality. No serious side effects or adverse reactions were reported with any of the formulations during primary immunization with three monthly injections of the vaccine. Eleven women, however, demonstrated hypersensitivity to test dose at the time of the booster injection. The reaction was to tetanus toxoid; gonadotropin subunits conjugated to another carrier did not evoke any such reaction. Progesterone in bleeds taken at midluteal phase, as well as complete progesterone and estradiol done in two immunized women, indicated normal ovulatory cycles. Immunization with these formulations had no significant effect on haematological, clinical chemistry and other metabolic parameters. In summary, the results indicate that none of the three beta-hCG-based contraceptive vaccines had any adverse effects clinically, on endocrine status and metabolic parameters. Formulations A and B induced comparatively higher anti-hCG titres than M. Thus, further work can be undertaken to study the efficacy of these vaccines in humans for preventing pregnancy.

journal_name

Contraception

journal_title

Contraception

authors

Talwar GP,Hingorani V,Kumar S,Roy S,Banerjee A,Shahani SM,Krishna U,Dhall K,Sawhney H,Sharma NC

doi

10.1016/0010-7824(90)90071-3

subject

Has Abstract,Author List Incomplete

pub_date

1990-03-01 00:00:00

pages

301-16

issue

3

eissn

0010-7824

issn

1879-0518

pii

0010-7824(90)90071-3

journal_volume

41

pub_type

临床试验,杂志文章,多中心研究
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    pub_type: 杂志文章

    doi:10.1016/s0010-7824(00)00188-8

    authors: Peters VM,Pinheiro NL,Reis JE,Guerra MO

    更新日期:2001-01-01 00:00:00

  • A comparative study of the levonorgestrel-releasing intrauterine system Mirena versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development.

    abstract:BACKGROUND:Mirena is a levonorgestrel-releasing intrauterine system (LNG-IUS) that provides highly effective and long-acting progestogen-only contraception. OBJECTIVE:The objective of this study was to analyze the possible effects of using LNG-20 microg IUS on breast-feeding performance, infant growth and infant devel...

    journal_title:Contraception

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.contraception.2005.04.004

    authors: Shaamash AH,Sayed GH,Hussien MM,Shaaban MM

    更新日期:2005-11-01 00:00:00

  • Pharmacokinetic profile of nomegestrol acetate and 17β-estradiol after multiple and single dosing in healthy women.

    abstract:BACKGROUND:The pharmacokinetics of the monophasic oral contraceptive nomegestrol acetate (NOMAC) plus 17β-estradiol (E(2)) were investigated after a single dose and multiple dosing. STUDY DESIGN:NOMAC/E2 (2.5 mg/1.5 mg) was administered daily to healthy women (18-50 years, n=23) for 24 days; blood samples for pharmaco...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2012.07.001

    authors: Gerrits MG,Schnabel PG,Post TM,Peeters PA

    更新日期:2013-02-01 00:00:00

  • Contraceptive sterilization use among married men in the United States: results from the male sample of the National Survey of Family Growth.

    abstract:BACKGROUND:Surgical sterilization has many advantages. Previous information on prevalence and correlates was based on surveys of women. STUDY DESIGN:We estimated the prevalence of vasectomy and tubal ligation of partners for male participants in the 2002 National Survey of Family Growth, a nationally representative su...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2010.03.018

    authors: Anderson JE,Warner L,Jamieson DJ,Kissin DM,Nangia AK,Macaluso M

    更新日期:2010-09-01 00:00:00

  • Hemostatic and metabolic effects of lowering the ethinyl-estradiol dose from 30 mcg to 20 mcg in oral contraceptives containing desogestrel.

    abstract::The metabolic and hemostatic effects of two oral contraceptives containing 150 mcg desogestrel and 20 mcg ethinyl-estradiol (EE) (MERCILON) or 30 mcg EE (MARVELON) were compared in order to examine the effect of reducing the EE dose in contraceptive pills. Forty-nine women participated in this randomized study during ...

    journal_title:Contraception

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/0010-7824(93)90141-s

    authors: Basdevant A,Conard J,Pelissier C,Guyene TT,Lapousterle C,Mayer M,Guy-Grand B,Degrelle H

    更新日期:1993-09-01 00:00:00

  • Vaginal misoprostol for late first trimester abortion.

    abstract::A group of 120 women with gestations from 64 to 84 days received 800 micrograms of vaginal misoprostol every 24 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/s0010-7824(98)00037-7

    authors: Carbonell Esteve JL,Varela L,Velazco A,Cabezas E,Tanda R,Sánchez C

    更新日期:1998-05-01 00:00:00

  • Associations between immediate postpartum long-acting reversible contraception and short interpregnancy intervals.

    abstract:OBJECTIVE:We aimed to evaluate the rates of short interpregnancy interval pregnancies and deliveries among women who receive immediate postpartum LARC. STUDY DESIGN:We conducted a retrospective cohort study of all women who delivered at Montefiore Medical Center between January 2015 and June 2016 (N = 9561). In this c...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2020.08.016

    authors: Wu M,Eisenberg R,Negassa A,Levi E

    更新日期:2020-12-01 00:00:00

  • Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y Jelly.

    abstract:BACKGROUND:New strategies are needed for preventing HIV infection in women. One potential approach is female-initiated use of an effective topical microbicidal gel in combination with a cervical barrier such as the diaphragm. STUDY DESIGN:Randomized, placebo-controlled safety and feasibility trial of diaphragm with va...

    journal_title:Contraception

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.contraception.2009.10.011

    authors: von Mollendorf CE,Van Damme L,Moyes JA,Rees VH,Callahan MM,Mauck CK,Puren AJ,Tweedy K,Taylor D

    更新日期:2010-03-01 00:00:00

  • Endometrial estradiol-17 beta-dehydrogenase activity in women wearing Cu-IUD.

    abstract::In order to determine whether inhibition of the endometrial estradiol-17 beta-dehydrogenase activity by Cu++ could be one of the factors accounting for the enhanced contraceptive efficacy of copper intrauterine devices (Cu-IUD), the activity of the enzyme was measured in endometrial biopsies from women wearing this de...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/0010-7824(79)90019-2

    authors: Tseng L,Dramusic V,Gurpide E

    更新日期:1979-03-01 00:00:00

  • Inhibition by gossypol of cyclic AMP production in mouse Leydig cells.

    abstract::Gossypol has been shown to inhibit steroidogenesis in leydig cells. This study examined the mechanism of this action by investigating the effect of gossypol on leydig cell hCG receptor binding, adenylate cyclase activity and cyclic AMP production in leydig cells. Gossypol had no effect on hCG binding to cell membranes...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/s0010-7824(86)80019-1

    authors: Pearce S,Sufi SB,O'Shaughnessy PJ,Donaldson A,Jeffcoate SL

    更新日期:1986-12-01 00:00:00

  • Use of a radioreceptor test for HCG in women practicing contraception.

    abstract::The importance of a simple, rapid and highly sensitive test for the diagnosis of early pregnancy cannot be overemphasized. In the present times when newer delivery systems of contraceptive agents and menstrual regulation procedures are increasingly used for fertility regulation, it is inevitable that confirmation of e...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/0010-7824(78)90039-2

    authors: Shahani SM,Kulkarni PP,Patel KL

    更新日期:1978-11-01 00:00:00

  • Medical methods of early abortion in developing countries. Consensus statement. The Population Council.

    abstract::Researchers, health care providers, women's health advocates, donors, and representatives of ministries of health convened in Bellagio, Italy, in July 1998, to assess the potential of medical methods of early pregnancy termination to improve the reproductive health of women in developing countries. Consensus was reac...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/s0010-7824(98)00109-7

    authors:

    更新日期:1998-11-01 00:00:00

  • The effects of progesterone and progestins on endometrial proliferation.

    abstract::A total of 99 premenopausal and 27 postmenopausal women were evaluated to determine the quantity of glandular proliferation resulting from progestin inhibition of estrogen-primed subjects and of subjects without hormonal stimulation. Endometrial glandular proliferation rates were determined by using mitosis counts, pr...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/s0010-7824(98)00047-x

    authors: Moyer DL,Felix JC

    更新日期:1998-06-01 00:00:00

  • Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials.

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    journal_title:Contraception

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/s0010-7824(01)00208-6

    authors: Coney P,Washenik K,Langley RG,DiGiovanna JJ,Harrison DD

    更新日期:2001-06-01 00:00:00

  • Exploring young women's decisional needs for contraceptive method choice: a qualitative study.

    abstract:OBJECTIVE:Assisting women with choosing contraceptive methods that meet their needs and preferences is essential to providing patient-centered care, but research to inform interventions supporting method choice is lacking. An assessment of patient decisional needs for contraceptive method choice may provide insight int...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2017.10.004

    authors: Marshall C,Kandahari N,Raine-Bennett T

    更新日期:2018-03-01 00:00:00

  • Bleeding patterns of adolescents using a combination contraceptive injection for 1 year.

    abstract:PURPOSE:This prospective observational study evaluated the bleeding patterns of adolescents receiving a monthly injectable contraceptive containing norethisterone enanthate 50 mg plus estradiol valerate 5 mg. MATERIALS AND METHODS:The study enrolled 73 volunteers aged between 14 and 19 years; of these patients, 38 (52...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2006.01.009

    authors: Bortolotti de Mello Jacobucci MS,Guazzelli CA,Barbieri M,Araújo FF,Moron AF

    更新日期:2006-06-01 00:00:00

  • Request and fulfillment of postpartum tubal ligation in patients after high-risk pregnancy.

    abstract:OBJECTIVE:Female sterilization is one of the most prevalent methods of contraception in the United States. Prior studies have shown that nearly half of postpartum tubal ligation (PPTL) requests go unfulfilled. This study seeks to establish whether obstetric or medical risk status influences patients' request for or sub...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2016.08.009

    authors: Albanese A,French M,Gossett DR

    更新日期:2017-03-01 00:00:00

  • A new experimental three-dimensional, reticular intrauterine device (3-DRIUD) composed of nitinol and silicone rubber.

    abstract:BACKGROUND:The aim of this study was to explore a new three-dimensional, reticular intrauterine device (3-DRIUD) composed of nitinol and silicone rubber and to observe the contraceptive effect of the device in rats. STUDY DESIGN:Two contraceptive experiments were performed. In the first, female rats underwent bilatera...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2012.10.031

    authors: Qiu Y,Wang LG,Zhang MH,Zhang YP,Zhang AD,Yang DT

    更新日期:2013-07-01 00:00:00

  • Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization.

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    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2010.01.019

    authors: Guiahi M,Goldman KN,McElhinney MM,Olson CG

    更新日期:2010-06-01 00:00:00

  • Comparison of outcomes at 6 weeks following postpartum intrauterine contraceptive device insertions by doctors and nurses in India: a case-control study.

    abstract:OBJECTIVE:As part of a strategy to revitalize postpartum family planning services, Government of India revised its policy in 2013 to permit trained nurses and midwives to insert postpartum intrauterine contraceptive devices (PPIUCDs). This study compares two key outcomes of PPIUCD insertions--expulsion and infection--f...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2015.12.012

    authors: Yadav V,Balasubramaniam S,Das S,Srivastava A,Srivastava A,Kumar S,Sood B

    更新日期:2016-04-01 00:00:00

  • A study of the relationship between tensile testing of condoms and breakage in use.

    abstract::The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from hol...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/0010-7824(91)90045-h

    authors: Gerofi J,Shelley G,Donovan B

    更新日期:1991-02-01 00:00:00

  • Challenging the stereotypes: men, withdrawal, and reproductive health in Lebanon.

    abstract::In Lebanon, coitus interruptus or withdrawal remains a widely practiced method of family planning. Our research sought to understand the role of men in reproductive health in Lebanon by focusing on this common practice. Our main questions were: Why is it that the practice persists when more effective modern methods of...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/s0010-7824(01)00304-3

    authors: Myntti C,Ballan A,Dewachi O,El-Kak F,Deeb ME

    更新日期:2002-02-01 00:00:00

  • Pharmacodynamic effects of once-a-month combined injectable contraceptives.

    abstract::The pharmacology and clinical assessment of existing first generation once-a-month combined injectable contraceptives, mainly Deladroxate and Chinese Injectable No. 1, are reviewed. Although these two types of monthly injectables have been used in some million women in China and Latin America, Deladroxate needs indept...

    journal_title:Contraception

    pub_type: 杂志文章,评审

    doi:10.1016/0010-7824(94)90033-7

    authors: Sang GW

    更新日期:1994-04-01 00:00:00

  • Triphasic combination of ethinyl estradiol and gestodene. Long-term clinical trial.

    abstract::A triphasic oral contraceptive containing ethinyl estradiol and gestodene was used by 1933 women for up to 36 cycles in order to evaluate contraceptive efficacy, general tolerance and cycle control. Altogether, 30,763 treatment cycles were recorded. Two pregnancies were seen, both of them classified as user failure. T...

    journal_title:Contraception

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1016/0010-7824(92)90128-g

    authors: Weber-Diehl F,Unger R,Lachnit U

    更新日期:1992-07-01 00:00:00

  • Deterioration in cardiometabolic risk markers in obese women during depot medroxyprogesterone acetate use.

    abstract:BACKGROUND:Highly effective contraception is essential in obese women, but it should not increase their risk of developing or worsening obesity-related cardiometabolic illness. The purpose of this 18-week prospective experimental study was to compare the impact of subcutaneous depot medroxyprogesterone acetate (DMPA-SC...

    journal_title:Contraception

    pub_type: 临床试验,杂志文章

    doi:10.1016/j.contraception.2011.04.016

    authors: Segall-Gutierrez P,Xiang AH,Watanabe RM,Trigo E,Stanczyk FZ,Liu X,Jurow R,Buchanan TA

    更新日期:2012-01-01 00:00:00

  • Utility and drawbacks of continuous use of a copper T IUD for 20 years.

    abstract::This article examines interrelated questions concerning the extent of need for contraception in women 40 years and older and the degree to which that need can be served when use of collared T IUDs is initiated in women aged 25-35 years. Differentials in the impacts of intrauterine device (IUD) use on health issues in ...

    journal_title:Contraception

    pub_type: 杂志文章,评审

    doi:10.1016/j.contraception.2007.01.016

    authors: Sivin I

    更新日期:2007-06-01 00:00:00

  • "And Isn't that the point?": pleasure and contraceptive decisions.

    abstract:OBJECTIVE:Previous survey research indicates that women and men experience reduced sexual pleasure when using condoms, especially compared to nonbarrier family planning methods. This study seeks to explore those experiences of reduced pleasure in-depth and how they affect contraceptive method decisions and use. STUDY ...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2013.11.012

    authors: Fennell J

    更新日期:2014-04-01 00:00:00

  • A phase I study of Femcap used with and without spermicide. Postcoital testing.

    abstract::The objectives of the study were to assess the ability of the Femcap, a new vaginal contraceptive device made of silicone and designed to fit snugly around the cervix to prevent the penetration of sperm into midcycle cervical mucus when used with and without spermicide; and to compare it with the standard contraceptiv...

    journal_title:Contraception

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0010-7824(97)00098-x

    authors: Mauck CK,Baker JM,Barr SP,Johanson W,Archer DF

    更新日期:1997-08-01 00:00:00

  • Safety of quinacrine contraceptive pellets: results from 10-year follow-up in Vietnam.

    abstract:BACKGROUND:This study was conducted to evaluate long-term safety of quinacrine pellets for nonsurgical sterilization among women in Vietnam. STUDY DESIGN:Observational cohort study of 2735 women who had quinacrine insertions between 1989 and 1993 compared to 1623 women who received an intrauterine device (IUD). RESUL...

    journal_title:Contraception

    pub_type: 杂志文章

    doi:10.1016/j.contraception.2008.02.011

    authors: Sokal DC,Hieu do T,Loan ND,Hubacher D,Nanda K,Weiner DH,Vach TH

    更新日期:2008-07-01 00:00:00

  • Comprehensive analysis of the use of pre-procedure ultrasound for first- and second-trimester abortion.

    abstract:BACKGROUND:The use of ultrasound (US) is common in some settings before an abortion procedure. However, its positive effect on the safety or efficacy (ability to complete abortion) of the procedure has not been established. Our aim was to determine whether the use of pre-procedure US improves safety and/or efficacy of ...

    journal_title:Contraception

    pub_type: 杂志文章,评审

    doi:10.1016/j.contraception.2010.06.014

    authors: Kulier R,Kapp N

    更新日期:2011-01-01 00:00:00