NCT00517556

Brief Summary

The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 18, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

May 18, 2007

Results QC Date

January 26, 2017

Last Update Submit

March 20, 2017

Conditions

Dysmenorrhea

Keywords

Dysmenorrheacontinuous OCP

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) Score

    Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.

    Baseline and 6 months

Study Arms (2)

study group (CCOCP)

EXPERIMENTAL

treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles

Drug: CCOCP

control group (traditional OCP)

ACTIVE COMPARATOR

treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.

Drug: Traditional OCP

Interventions

CCOCPDRUG

(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol

Also known as: Oral contraceptives
study group (CCOCP)
Traditional OCPDRUG

(traditional OCP) (21 active days/7 inactive days) treatment regimen

Also known as: Oral contraceptives
control group (traditional OCP)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women ages 18-35 with a history of PD (onset \< 3 years after menarche).
  • Subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe PD during those cycles.

You may not qualify if:

  • Patients who have contraindications to OCP therapy.
  • Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).
  • Concomitant treatment with oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
  • The use of contraceptive implants, injectable contraceptives or intrauterine devices. The washout period on all these medications will be 3 months.
  • Migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use.
  • Known or suspected hypersensitivity to trial drug.
  • Patients enrolled simultaneously into other investigative studies that require meds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Gradiska General Hospital

Strossmayerova 17, Croatia

Location

Related Publications (2)

  • Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

    PMID: 37523477DERIVED

  • Dmitrovic R, Kunselman AR, Legro RS. Continuous compared with cyclic oral contraceptives for the treatment of primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1143-50. doi: 10.1097/AOG.0b013e318257217a.

    PMID: 22617578DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Results Point of Contact

Title
Richard S. Legro, M.D.
Organization
The Milton S. Hershey Medical Center
rsl1@psu.edu
717-531-6210

Study Officials

  • Richard S Legro, M.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

May 18, 2007

First Posted

August 17, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

April 28, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-03

Locations

CR(1)