Health TrialsbyHealthPanel

Investigating Ovulation Inhibition for Use as a Contraceptive

ConditionContraception
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMylan Pharmaceuticals Inc

About this trial

A single-centre, open-label, randomised, phase II study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with MR 130A 01 contraceptive transdermal patch

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive) at screening examination.

Disqualifiers

1. Known hypersensitivity or intolerance to any ingredient of the investigational product.

Short-acting hormonal contraceptives such as oral, patch, ring or intrauterine systems within the menstrual cycle prior to the pre-treatment cycle.

Injectable (intramuscularly or subcutaneously) within 10 months (three-month treatment duration), 6 months (two-month treatment duration) or 3 months (one-month treatment duration) prior to the start of pre-treatment cycle or implants within the menstrual cycle prior to the pre-treatment cycle.

Trial design

Design model

Crossover

Treatments tested in this trial

  • MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)

    Drug

    MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: "regular": regular application without planned application errorsExperimental treatment 1 intervention
Group B: Extended Period 1: regular application with planned application errorsExperimental treatment 1 intervention
Group C: Extended Period 2: regular application with planned application errorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ovulation incidence in cycle with regular application, and in cycles with extended period application errors. Ovulation is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

Time frame
84 days

Secondary outcomes

1

Ovulation incidence overall and incidence per treatment cycle.

Time frame
84 days
2

HSS determined for each treatment cycle.

Time frame
84 days
3

Fulfilment of Landgren criterion in cycles with HSS 5 or 6.

Time frame
84 days
4

FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS).

Time frame
84 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mylan Pharmaceuticals Inc

Lead sponsor

Source ClinicalTrials.gov
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