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PubMed2004

Low-dose topical delivery of all-trans retinoic acid for cervical intraepithelial neoplasia II and III.

OBJECTIVE: The objective of this study was to determine an effective dose for all-trans retinoic acid (atRA) delivered with a cervical cap and sponge for 4 days to women with cervical intraepithelial neoplasia (CIN) II/III. METHODS: Study participants made up of 175 women with biopsy-proven CIN II/III were randomized to four consecutive days of atRA at one of three doses (0.16%, 0.28%, and 0.36%) or placebo. All subjects underwent a repeat colposcopy evaluation and biopsy of the cervix at 12 weeks. RESULTS: The study participants mean ages were 27.6 years. The racial distribution was 63% Caucasian, 27% African American, and 8% other. Among participants, 93% were human papillomavirus-positive at baseline with 68% positive for high-risk types. The disease response at 12 weeks to atRA or placebo was not significantly different (P = 0.49) among the four dose groups. Participants with CIN II at baseline were more likely to be free of disease at 12 weeks than participants with CIN III at baseline (P = 0.003). There were no reported systemic adverse events related to drug or placebo exposure and only mild local self-reported and clinician-detected toxicities. CONCLUSION: Lower concentrations of atRA applied with a cervical cap for 4 days were no more effective than placebo. However, the rate of histologic regression in biopsied CIN II/III patients was high even over a short time interval, and emphasizes the importance of having a placebo arm and an adequate sample size.

Adolescent↗
PubMed1991

Failure of intrauterine insemination in a refractory infertility population.

Intrauterine insemination by itself for multiple and/or severe infertility factors had no benefit over cervical cap with whole ejaculate or coitus in this study. The PRs for IUI and cervical cap with whole ejaculate or coitus were similar and low, suggesting that IUI by itself has limited, if any, utility in enhancing PRs in this type of infertility population. Couples attempting IUI should be advised about the low probability of achieving pregnancy. Ovulation stimulation and/or heterologous donor insemination, IVF, or gamete intrafallopian transfer may be beneficial therapeutic options.

Adult↗
PubMedDate not supplied

Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic↗
PubMed1994

Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial.

BACKGROUND: Retinoids enhance differentiation of most epithelial tissues. Epidemiologic studies have shown an inverse relationship between dietary intake or serum levels of vitamin A and the development of cervical dysplasia and/or cervical cancer. Pilot and phase I investigations demonstrated the feasibility of the local delivery of all-trans-retinoic acid (RA) to the cervix using a collagen sponge insert and cervical cap. A phase II trial produced a clinical complete response rate of 50%. PURPOSE: This randomized phase III trial was designed to determine whether topically applied RA reversed moderate cervical intraepithelial neoplasia (CIN) II or severe CIN. METHODS: Analyses were based on 301 women with CIN (moderate dysplasia, 151 women; severe dysplasia, 150 women), evaluated by serial colposcopy, Papanicolaou cytology, and cervical biopsy. Cervical caps with sponges containing either 1.0 mL of 0.372% beta-trans-RA or a placebo were inserted daily for 4 days when women entered the trial, and for 2 days at months 3 and 6. Patients receiving treatment and those receiving placebo were similar with respect to age, ethnicity, birth-control methods, histologic features of the endocervical biopsy specimen and koilocytotic atypia, and percentage of involvement of the cervix at study. Treatment effects were compared using Fisher's exact test and logistic regression methods. Side effects were recorded, and differences were compared using Fisher's exact test. RESULTS: RA increased the complete histologic regression rate of CIN II from 27% in the placebo group to 43% in the retinoic acid treatment group (P = .041). No treatment difference between the two arms was evident in the severe dysplasia group. More vaginal and vulvar side effects were seen in the patients receiving RA, but these effects were mild and reversible. CONCLUSIONS: A short course of locally applied RA can reverse CIN II, but not more advanced dysplasia, with acceptable local side effects. IMPLICATIONS: A derivative of vitamin A can reverse or suppress an epithelial preneoplasia, lending further support to the notion that chemoprevention of human cancer is feasible.

Administration, Intravaginal↗
PubMed2001

Contraception in the adolescent: an update.

Contraception remains an important part of national efforts to reduce adolescent pregnancy in the United States. A number of safe and effective contraceptive methods are available for our youth, including abstinence, barrier methods, oral contraceptives, Depo-Provera, and Norplant. Research over the past few decades has resulted in a variety of oral contraceptives with reduced amounts of hormones and reduced side-effects. A number of methods have received approval by the Food and Drug Administration since the last review in 1980, including emergency contraceptives, depomedroxyprogesterone acetate, and the cervical cap. The use of condoms and vaginal spermicides continues to be recommended for all sexually active adolescents to reduce (not eliminate) the risk for acquiring sexually transmitted diseases. A polyurethane condom is now available, in addition to the latex condom and other barrier contraceptives, including the following: diaphragm, cervical cap, vaginal sponge, female condom and vaginal spermicides. Because of continuing concerns about pelvic inflammatory disease related to intrauterine devices, currently available intrauterine devices are not recommended for most adolescents. Abortion is not considered as a contraceptive method.

Adolescent↗
PubMed1999

Family planning training in Maryland family practice and obstetrics/gynecology residency programs.

OBJECTIVE: To examine the extent of family planning and abortion training in Maryland family practice (FP) and obstetrics/gynecology (OB) residency training programs. METHODS: All final-year residents in every FP and OB residency training program in Maryland were asked in 1998 how many cases (0, 1-10, > 10) of ten methods of contraception and abortion they had managed. RESULTS: Seventy-five percent (55) of the 73 residents responded. Fifty percent of FP residents had never inserted an intrauterine device (IUD), 43% had never inserted an implant (Nor-plant), 37% had never prescribed emergency contraceptive pills, and 30% had never fitted a diaphragm. Ninety-seven percent of FP residents had no experience with elective termination of pregnancy, and 83% had no experience with sterilization. Twenty percent of OB residents had never inserted an IUD, 16% had never inserted implants or prescribed emergency contraceptive pills, 20% had never fitted a diaphragm, and 36% had no experience in elective termination of pregnancy. Not one FP resident had inserted or fitted more than ten IUDs, implants, diaphragms, or cervical caps. Except for oral and injectable contraception, the majority of OB residents had not managed more than ten cases of any other reversible contraceptive method: 80% had not inserted more than ten IUDs, 72% had not inserted more than ten implants, 88% had not fitted more than ten diaphragms, and 100% had not fitted more than ten cervical caps. CONCLUSION: These survey results indicate a need for more formal instruction in most contraceptive methods for OB and FP residency programs in Maryland. This study concurs with previous national studies showing deficits in family planning training.

Contraceptive Devices, Female↗
PubMed2000

Effects of contraceptive method on the vaginal microbial flora: a prospective evaluation.

A prospective evaluation of 331 university women who were initiating use of oral contraceptive pills (OCPs), a cervical cap, diaphragm-spermicide, or other spermicidal methods was done to assess the effects of commonly used contraceptive methods on the vaginal flora. Vaginal introital cultures were performed at baseline and then weekly for 1 month. The prevalence of Escherichia coli vaginal colonization and of abnormal vaginal Gram stain scores (Nugent criteria) increased significantly among women using a cervical cap or diaphragm-spermicide but not among women using OCPs. Women with E. coli colonization were significantly more likely to have an abnormal Nugent score and an absence of lactobacilli. In a multivariate model, use of spermicidal contraception in the preceding week was associated with an abnormal Nugent score and with colonization with E. coli, Enterococcus species, and anaerobic gram-negative rods. Thus, spermicidal methods of contraception are associated with alterations of the vaginal microflora that consequently may predispose women to genitourinary infections.

Adolescent↗
PubMed1996

Topical 5-fluorouracil in the treatment of cervical human papillomavirus infection.

Chemosurgical treatment of vaginal/cervical human papillomavirus (HPV) infection with 5-fluorouracil (5-FU) is limited by vulvar pain and dysuria resultant from leakage and vulvar/urethral tissue reaction to the 5-FU. Women with cervical HPV DNA identified by in situ hybridization on colposcopically directed biopsy were treated with topically applied 5% 5-FU cream. A fitted cervical cap was used to restrict exposure to 5-FU. Repeat biopsies and in situ hybridization at least 6 weeks after application failed to detect HPV DNA in 6 of 7 patients. In 1 case, 5-FU treatment was associated with a decreased intensity of detectable HPV DNA. No episodes of vulvar pain or dysuria occurred. 5-FU can be used in the treatment of cervical HPV with minimal side effects when applied utilizing a cervical cap.

Administration, Topical↗
PubMed1984

Artificial hydramnion. A simple method of verifying premature rupture of the membranes.

Accurate diagnosis of premature rupture of the membranes is of paramount importance for proper treatment. Currently available methods of diagnosing this complication of pregnancy are not satisfactory. A new, simple, noninvasive method occludes the amniotic outflow with a cervical cap on the external cervical os, permitting the formation of an artificial hydramnion. Observation of this hydramnion formation using ultrasonography and the release of accumulated amniotic fluid after removal of the cap are strong evidence of the existence of premature rupture of the membranes. We used this method in 17 cases.

Adult↗
PubMed1986

Vaginal colonization with Escherichia coli in healthy women. Determination of relative risks by quantitative culture and multivariate statistical analysis.

The rate of vaginal colonization with Escherichia coli in 495 healthy women was 12% in a prospective study with use of selective media and semiquantitative culture techniques. Computer-assisted multivariate analysis revealed that vaginal E. coli was significantly associated with the menstrual phase of the cycle, prior use of antibiotics, use of diaphragm or cervical cap for contraception, history of previous urinary tract infection, and coisolation of Staphylococcus aureus that was positive for the toxic shock syndrome toxin-1 (p less than 0.05, multiple stepwise logistic regression analysis). No significant association was observed with tampon use or brand, other contraceptive methods, sexual activity, genital symptoms, recent vaginal infection, or other personal habits. Quantitative cultures obtained sequentially throughout the menstrual cycle in 12 unselected women confirmed higher E. coli counts in menstrual or midcycle samples compared to paired premenstrual specimens (p less than 0.05, Wilcoxon paired rank sign test). These data emphasize the hormonal and other host determinants in vaginal colonization by E. coli and may explain the high rate of vaginal E. coli (64%), in addition to toxicogenic S. aureus, in acute toxic shock syndrome and the higher incidence of urinary tract infection in women with diaphragm or cervical cap for contraception compared to other contraceptive methods.

Adult↗
PubMed1997

Photodynamic therapy using topically applied dihematoporphyrin ether in the treatment of cervical intraepithelial neoplasia.

OBJECTIVE: To perform a phase I study of topically applied dihematoporphyrin ether (DHE) in the photodynamic treatment (PDT) of cervical intraepithelial neoplasia (CIN) using fixed DHE doses and application schedules, and a variable dose of 630 nm red light delivered by an argon-pumped dye laser. METHODS: Between February 1993 and April 1994, 24 nonpregnant women with a histologic diagnosis of CIN were enrolled. All patients had lesions involving at least 25% of the cervix that were colposcopically visible. Using a cervical cap, 2 ml of a 1% solution of DHE (Photofrin) in a 4% Azone and isopropyl alcohol vehicle were applied to the cervix 24 hr prior to PDT. An argon-pumped dye laser providing light at 630 nm was then used to perform PDT. Light was coupled into a 400-microm silica fiber optic terminating in a microlens which focused the laser radiation onto a circular field of uniform light intensity perpendicular to the tissue. The entire ectocervix was treated in a single field including a margin of 3-5 mm of normal cervix. Using a constant power density (150 mW/cm2) to avoid thermal injury, the PDT energy was increased every 4 patients in a phase I fashion (40, 60, 80, 100, 120, and 140 J/cm2). RESULTS: Thirteen patients with CIN I, 7 patients with CIN II, and 4 patients with CIN III were treated. The maximal energy density was well tolerated. Toxicity was minimal with no patients experiencing local necrosis, sloughing, or scarring; however, a mild vaginal discharge was noted in several patients. Systemic effects were absent. After 12 months of follow-up at 3-month intervals, 22 patients are evaluable of whom 15 (68%) are disease free. One patient was lost to follow-up and in another the cervical cap was dislodged. Four of the 7 failures or recurrences occurred at energy densities of 80 J/cm2 or less, while 8 of 11 (73%) patients were treated successfully with PDT at an energy density of 100 to 140 J/cm2. CONCLUSIONS: PDT with DHE and an argon-pumped dye laser at 630-nm wavelength delivering an energy density of 140 J/cm2 is safe and effective in treating CIN. Phase II studies using PDT at the prescribed application schedule and dose are indicated.

Administration, Topical↗
PubMed1991

New female intravaginal barrier contraceptive device. Preliminary clinical trial.

The Fem Cap, a silicone rubber cervical cap, is shaped like a sailor's hat. While its dome covers the cervix, its rim fits snugly into the vaginal fornices, and its brim adheres and conforms to the vaginal walls. A spermicidal material is applied to the cap, then it is positioned over the cervix by hand or with a special applicator. The device is removed by hand up to 48 hours after insertion, but no sooner than eight hours after intercourse. Women chosen for the trial had contraindications to or were dissatisfied with the currently available contraceptive methods. Each woman was fitted with a cap of suitable size and instructed in its use. She was then asked to note any side effects and the dates of her menses in a diary. One-hundred-twenty-one women were enrolled in the study. Five became pregnant. Of those, two reported dislodgment of the cap during intercourse; the other three admitted to non-use of the cap on several occasions. This device has proven so far to be safe, effective and acceptable to women and men. It has several advantages over the currently available barrier contraceptive devices. The silicone rubber material from which it is made is non-allergenic, durable and easy to clean. Its design fits the anatomy and accommodates physiological changes. The Fem Cap is easy to insert and remove; an applicator facilitates insertion for some women. Instruction for use of the device requires short time from the health care provider.

Adolescent↗
PubMed1983

Vaginal mechanical contraceptive devices.

The alleged adverse effects of oral contraceptives and intrauterine devices have led to increased consumer and physician demand for vaginal contraceptive devices. The efficacy and the advantages and disadvantages of vaginal sponges, cervical caps and diaphragms are discussed and compared in this article.

Contraceptive Agents, Female↗
PubMed1988

Effect of butoconazole nitrate cream and wax insert on the barrier property of contraceptive devices.

A new method was developed to assess the quality of the barrier property of several types of commonly used contraceptive devices (diaphragm, cervical cap, and condom). Our data showed that butoconazole nitrate cream and wax inserts did not affect the barrier property of the contraceptive devices when the products were placed in contact with the devices for up to 72 hours at 37 degrees C.

Antifungal Agents↗
PubMed1988

Notice, 11 July 1988.

On 11 July 1988, the US Food and Drug Administration approved the use of the cervical cap as a contraceptive. The cap is to be used in conjunction with a spermicidal cream or jelly to prevent pregnancy. It must be left in place for a minimum of eight hours after intercourse and may be left in place for a maximum of 48 hours.

Americas↗
PubMedDate not supplied

Contraceptive failure in the United States: an update.

This report provides an update of the authors' previous estimates of first-year probabilities of contraceptive failure for all methods of contraception. Estimates are provided of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct use at every act of intercourse). The difference between these two probabilities provides a measure of how forgiving of imperfect use each method is. These revisions are prompted by recent studies that provide the first estimates of failure during perfect use for periodic abstinence and the cervical cap, by more complete evaluations of implants, and by the appearance of the Copper T 380A and disappearance of other IUDs from the US market. Also provided is a more complete explanation of how the previous estimate of the probability of becoming pregnant while relying solely on chance should be interpreted, and this estimate is revised slightly downward.

Clinical Trials as Topic↗
PubMed1989

Adolescent contraception: nonhormonal methods.

A comparison of the advantages, disadvantages, and costs of each method is presented in Table 1. Barrier methods of contraception offer adolescents protection against both pregnancy and STDs, but innovative approaches are needed to enhance availability and acceptability. Condom use in conjunction with a vaginal spermicide would provide optimal protection. The "female condom" may prove to be an effective alternative. Diaphragms and cervical caps can be prescribed for well-educated, highly motivated adolescents comfortable with insertion and removal. The vaginal contraceptive sponge provides many of the advantages of the diaphragm and cap without the need for an examination and fitting and also may be used as a backup method with the condom. Vaginal spermicides used alone are significantly less effective than in combination with a mechanical barrier. The IUD is not considered appropriate for most adolescents due to its association with an increased risk of pelvic infection. Periodic abstinence requires accurate identification of the fertile period, extensive education, and partner cooperation. Sterilization is rarely considered an option in adolescents. Alternate forms of sexual expression are available to adolescents who choose to abstain from intercourse.

Adolescent↗
PubMed2004

Time-dependent hexaminolaevulinate induced protoporphyrin IX distribution after topical application in patients with cervical intraepithelial neoplasia: A fluorescence microscopy study.

BACKGROUND AND OBJECTIVES: Compared to the conventional management of cervical intraepithelial neoplasia (CIN) the potential advantage of photodynamic therapy (PDT) for the treatment of cervical human papilloma virus (HPV)-related disease encompasses a minimal invasive procedure with reduced risk of profuse bleeding as a consequence of conization, and possibly more favorable long-term results avoiding cervical stenosis. At present little is known about the precise time-dependent distribution and histological localization of hexaminolaevulinate (HAL) induced protoporphyrin IX (PPIX) fluorescence in healthy tissue and in CIN. The aim of this study was to use ex vivo fluorescence microscopy to determine whether PPIX is selectively induced by neoplastic cells of the cervical epithelium at various times after topical application. STUDY DESIGN/MATERIALS AND METHODS: Cold cream containing 0.5% HAL was applied by means of cervical cap over various periods of time. We analyzed 52 healthy cervical mucosa and 84 CINs. RESULTS: At time delay 100 (+/-10) minutes, high epithelial fluorescence and a significant selectivity between epithelium and underlying lamina propria was found. By contrast, no significant difference between healthy and neoplastic tissues, or between low and high-grade epithelial dysplasia (P > or = 0.05), was observed at any time point. CONCLUSIONS: Application of HAL 0.5% cream to the cervix induced selective fluorescence in epithelial cells. The optimal ratio with a homogeneous PPIX distribution was obtained after 100 ( +/- 10) minutes cream application, which should be evaluated further for PDT.

Administration, Topical↗