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A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use.

ABSTRACT: Unscheduled bleeding is the main side effect of continuous oral contraceptive pills (OCPs) and has been correlated with the up-regulation of matrix metalloprotineases (MMPs). The study objective was to determine if prophylactic administration of doxycycline (an MMP inhibitor at low subantimicrobial doses) would prevent unscheduled bleeding during the initiation of a continuous OCP.Subjects using cyclic hormonal contraceptives (combined OCPs, patch or ring) without unscheduled bleeding were switched to continuous OCPs (20 mcg ethinyl estradiol/100 mcg levonorgestrel). They were randomized to receive daily doxycycline [sustained-release subantimicrobial dose (40 mg daily)] or placebo for the first 84 days and then observed for an additional 28 days on the continuous OCP alone. The number of bleeding/spotting days and the time in days it took to achieve amenorrhea were compared using a t test.Sixty-five subjects were randomized. Although the use of doxycycline did not significantly decrease the number of mean bleeding/spotting days in the first 84 days of the study [doxycycline 14.75 (SE 2.30), placebo 17.78 (2.31), p=.36], women who received doxycycline had a significantly earlier onset of amenorrhea [mean last day of bleeding/spotting doxycycline 61.7 (7.7), placebo 85.2 (6.7), p=.03].The coadministration of subantimicrobial-dose doxycycline during initiation of continuous OCPs results in a significant reduction in the length of time needed to achieve amenorrhea.

SUBMITTER: Kaneshiro B

PROVIDER: S-EPMC5045031 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use.

Kaneshiro Bliss B Edelman Alison A Carlson Nichole E NE Nichols Mark M Forbes Marci Messerle MM Jensen Jeffrey J

Contraception 20110928 4

<h4>Background</h4>Unscheduled bleeding is the main side effect of continuous oral contraceptive pills (OCPs) and has been correlated with the up-regulation of matrix metalloprotineases (MMPs). The study objective was to determine if prophylactic administration of doxycycline (an MMP inhibitor at low subantimicrobial doses) would prevent unscheduled bleeding during the initiation of a continuous OCP.<h4>Study design</h4>Subjects using cyclic hormonal contraceptives (combined OCPs, patch or ring) ...[more]

PMID: 22067758

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Project description:ObjectiveData regarding the use and effect of hormonal contraceptives on bone mass acquisition during adolescence are contradictory. The present study was designed to evaluate bone metabolism in two groups of healthy adolescents using combined oral contraceptives (COC).MethodsA total of 168 adolescents were recruited from 2014 to 2020 in a non-randomized clinical trial and divided into three groups. The COC1 group used 20 μg Ethinylestradiol (EE)/150 μg Desogestrel and the COC2 group used 30 μg EE/3 mg Drospirenone over a period of two years. These groups were compared to a control group of adolescent non-COC users. The adolescents were submitted to bone densitometry by dual-energy X-ray absorptiometry and measurement of bone biomarkers, bone alkaline phosphatase (BAP), and osteocalcin (OC) at baseline and 24 months after inclusion in the study. The three groups studied were compared at the different time points by ANOVA, followed by Bonferroni's multiple comparison test.ResultsIncorporation of bone mass was greater in non-users at all sites analyzed (4.85 g in lumbar Bone mineral content (BMC)) when compared to adolescents of the COC1 and COC2 groups, with a respective increase of 2.15 g and loss of 0.43g in lumbar BMC (P = 0.001). When comparing subtotal BMC, the control increased 100.83 g, COC 1 increased 21.46 g, and COC 2 presented a reduction of 1.47 g (P = 0.005). The values of bone markers after 24 months are similar for BAP, being 30.51 U/L (± 11.6) for the control group, 34.95 U/L (± 10.8) for COC1, and 30.29 U/L for COC 2 (± 11.5) (P = 0.377). However, when we analyzed OC, we observed for control, COC 1, and COC 2 groups, respectively, 13.59 ng/mL (± 7.3), 6.44 ng/mL (± 4.6), and 9.48 ng/mL (± 5.9), with P = 0.003. Despite loss to follow-up occurring in the three groups, there were no significant differences between the variables in adolescents at baseline who remained in the study during the 24-month follow-up and those who were excluded or lost to follow-up.ConclusionBone mass acquisition was compromised in healthy adolescents using combined hormonal contraceptives when compared to controls. This negative impact seems to be more pronounced in the group that used contraceptives containing 30 μg EE.Clinical trial registrationhttp://www.ensaiosclinicos.gov.br, RBR-5h9b3c. "Low-dose combined oral contraceptive use is associated with lower bone mass in adolescents".

Project description:CONTEXT:Female athletes aged 14 to 18 years are at particular risk for anterior cruciate ligament (ACL) injuries. Hormonal factors are thought to predispose them to this injury. Oral contraceptive pills (OCPs) might reduce ACL injury risk, although the literature appears controversial. OBJECTIVE:To evaluate the association between OCP use and ACL injuries in women. The secondary objective was to determine the rates of ACL injuries in the pre- and postovulatory phases of the menstrual cycle in OCP and non-OCP (NOCP) users. DATA SOURCES:Searches were performed across 4 reference databases (PubMed, CINAHL, Embase, Cochrane), abstracts from 6 specialty societies, ClinicalTrials.gov , and reference lists of relevant papers. STUDY SELECTION:We included studies investigating the association between OCP use and ACL injuries in females of any age or the distribution of ACL injuries across the menstrual cycle in OCP and NOCP users. STUDY DESIGN:Systematic review. LEVEL OF EVIDENCE:Level 3. DATA EXTRACTION:Data regarding study design, population characteristics, OCP details, outcome definitions, analytic methods, and results were extracted from the included studies. The methodological quality of each study was assessed using the Newcastle-Ottawa scale. RESULTS:The search yielded 1305 citations, of which 7 retrospective observational studies met the inclusion criteria. Two large case-control studies with higher methodological quality suggested that OCP use may reduce the risk of sustaining an ACL injury. Five comparative studies examining injury distribution across the menstrual cycle in OCP and NOCP users had conflicting findings, were heterogeneous, and were limited by low methodological quality. CONCLUSION:The evidence suggests OCP use may reduce the risk of ACL injury; however, no conclusions can be drawn regarding differences in risk of ACL injuries between OCP and NOCP users across the menstrual cycle. Studies were limited by small sample sizes, heterogeneity, and methodological concerns.

Project description:Background: Oral contraceptive (OCP) use might increase the risk of stroke in women. We examined a possible dose-response relation between OCP use and the risk of stroke in young and middle-aged women. Methods: A retrieval of PubMed and EMBASE databases was performed. We selected observational studies that reported odds ratios (ORs) with 95% confidence intervals (CIs) for the risk of stroke in OCP users. A two-stage dose-response analysis was conducted using the random-effects model and the restricted spline model. Results: A total of 6 cohort studies and 12 case-control studies were included, which involved 2,143,174 participants and 11,661 cases of stroke including ischemic stroke (IS), hemorrhagic stroke (HS), and stroke of unknown origin. The pooled ORs of total stroke were 1.19 (95% CI, 1.16-1.23) for every 10-?g increment in estrogen dosage, 1.20 (95% CI, 1.05-1.37) for every 5-years increment in duration of OCP use, and 0.82 (95% CI, 0.68-0.98) for every 5-years increment in duration of OCP cessation. The ORs of IS were 1.20 (95% CI, 1.17-1.22) in estrogen dosage, 1.24 (95% CI, 1.04-1.49) in duration of OCP use, and 0.78 (95% CI, 0.67-0.92) in duration of OCP cessation. The ORs of HS were 1.10 (95% CI, 1.04-1.16) in estrogen dosage, 1.13 (95% CI, 0.93-1.36) in duration of OCPs, and 0.71 (95% CI, 0.55-0.92) in duration of OCP cessation. The pooled ORs of total stroke from prospective studies (1.12; 95% CI, 1.01-1.24) were lower than those from retrospective studies (1.30; 95% CI, 1.01-1.67). Conclusions: The higher estrogen dosage significantly increased the risks of total stroke, IS, and HS, respectively. The longer duration of OCP use significantly increased the risks of total stroke and IS, but its effects on HS risk were marginal. The longer duration of OCP cessation significantly decreased the risks of total stroke, IS, and HS, respectively. These findings affirm the contribution of estrogen dose and duration of OCP use to the increased risk of stroke, which may be critical for the instruction of OCP use and the prevention and management of cerebrovascular diseases.

Dataset Information

A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use.

Publications

A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use.

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