NCT03531437

Brief Summary

The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

January 11, 2016

Last Update Submit

May 8, 2018

Conditions

ContraceptionHypercoagulability

Outcome Measures

Primary Outcomes (1)

  • D-dimer

    µg/L

    12 weeks

Secondary Outcomes (3)

  • fibrinogen

    12 weeks

  • antithrombin III

    12 weeks

  • to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®

    12 weeks

Study Arms (2)

Zoely

ACTIVE COMPARATOR

Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles

Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate

Minidoz

ACTIVE COMPARATOR

Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles

Drug: 15 µg ethinylestradiol and 60 µg gestodene

Interventions

1.5 mg estradiol and 2.5 mg nomegestrol acetateDRUG
Also known as: Zoely®
Zoely
15 µg ethinylestradiol and 60 µg gestodeneDRUG
Also known as: Minidoz®
Minidoz

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman age 19-40 yr
  • Normal uterus and both adnexae
  • BMI \< 28.5 kg/m2
  • Require contraception with COCs

You may not qualify if:

  • Pregnancy
  • Postartum period within 6 wk
  • Smoking
  • BP ≥ 140/90 mmHg
  • Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
  • use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system
  • Use contraceptive steroids within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombophilia

Interventions

Estradiolnomegestrol acetateEthinyl EstradiolGestodene

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorpregnatrienesNorpregnanesNorsteroidsEstrogenic Steroids, Alkylated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Siriraj hospital

Study Record Dates

First Submitted

January 11, 2016

First Posted

May 21, 2018

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 18, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05