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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02957292
Other study ID # IIBSP-DIU-2015-85
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2016
Est. completion date September 15, 2020

Study information

Verified date October 2021
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age. Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea. In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs. The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users. This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date September 15, 2020
Est. primary completion date September 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy female subject. - Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method. - History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss. Exclusion Criteria: - Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria. - Contraindications to use 13,5 LNG-IUD. - Anemia. - Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion. - Known bleeding irregularities. - Pregnancy or breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levonorgestrel (13,5 mg) intrauterine device

Device:
Cooper (380mm2) intrauterine device


Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of menstrual bleeding days Daily recorded during 90 days treatment period 90 days
Primary Amount of Menstrual bleeding Classified using a 5-item Likert-like scale from none to heavy, a pictorial blood loss assessment chart (PBAC), and ferritin and haemoglobin blood test determinations 90 days
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