NCT01791413

Brief Summary

The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 23, 2013

Completed
Last Updated

September 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

February 10, 2013

Results QC Date

June 18, 2013

Last Update Submit

August 23, 2013

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation

    Within the first 2 weeks and 3 months after surgery

Study Arms (2)

depot medroxyprogesterone acetate

ACTIVE COMPARATOR
Drug: depot medroxyprogesterone acetate

No depot medroxyprogesterone acetate

NO INTERVENTION

Interventions

depot medroxyprogesterone acetateDRUG

DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)

depot medroxyprogesterone acetate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women 18-40 years old
  • A diagnosis of endometrioma with diameter of at least 3 cm.
  • Candidates for laparoscopic cystectomy

You may not qualify if:

  • Patients' refusal to participate
  • Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
  • Use of estrogen-suppressive drugs in the preceding 3 months, such as:
  • Oral contraceptives, GnRH analogues, Progestins, Danazol
  • Pathology report present no endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

Small sample size

Results Point of Contact

Title
Dr. Weena Krutsawad
Organization
Mahidol University
vna_fe2@hotmail.com
66812070264

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 10, 2013

First Posted

February 15, 2013

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 9, 2013

Results First Posted

August 23, 2013

Record last verified: 2013-08

Locations

TH(1)