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The Effect of Oral Contraceptives on Women Balance

NCT02855294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-08-04

No results posted yet for this study

Summary

1. Recording Data Sheet:

All data and information of each woman in both groups (A \& B) participated in this study were recorded in a recording data sheet (Appendix II).
2. Weight-Height scale:

A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight, and 1 to 200 centimeters height was used to measure the relevant subject's data.
3. Siemens Immulite Immunoassay System:

(Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A) to measure the serum Progesterone and Estradiol levels in both groups (A\& B) using (TKE 21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.
4. Biodex balance system:

Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows approximately 20 degree inclination in 360 degree range and is interfaced with computer software. It measures the patient's ability to control the platform's angle of tilt, which is quantified as a variance from the center, as well as the degree of deflection over time at various stability levels as shown in (Fig. 6).

Stability levels allowed by the system ranged from one to eight. Stability level 8, allows the highest level of stability as it makes the platform to be the least tilted. On the other hand, stability level one represents the least level of stability and is more difficult for the subject to maintain stability on.

The test consists of recording the patient's ability to control the platform variance from a perfectly balanced position. A large variance is indicative of poor control and balance. Further definition is realized with the quantification of Anterior/ Posterior and Medial/Lateral responses.

Conditions

  • Joint Stabilioty

Interventions

DRUG

COC containing 30 μg of EE and 3mg of drospirenone

treatment for 6 consecutive cycles. Each treatment cycle consisted of 3 weeks of pill treatment followed by a 1-week pill-free period.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Kasr Alainy medical school

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855294 on ClinicalTrials.gov