Why do Oral Contraceptives Prevent Ovarian Cancer?

NCT02155777 | Completed Early Phase 1

• 2 other identifiers: OC Prevention1R21CA178571-01
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 3

Brief Summary

Use of oral contraceptives (OCs) reduces a woman's risk of ovarian cancer very significantly and the protective effect continues for at least 25 years after use of OCs is stopped; the mechanisms of how this occurs are not understood. We are proposing here to directly study the effect of OCs on the fallopian tube and inclusion cysts within the ovary - sites from which most ovarian cancers are thought to arise - in order to better understand the mechanistic basis for OC protection against ovarian cancer. We think the protection results from reduced cell proliferation. It will lay the foundation for further studies to ensure that the protection against ovarian cancer afforded by 'traditional' OCs is not lost with alterations in OC formulation, and, if possible, to guide development of OC formations to improve further on the protection afforded by OCs.

Conditions

Ovarian Cancer Risk; Risk-reducing Surgery; Fallopian Tube Fimbriae; Ovarian Cortical Inclusion Cysts

Keywords

BRCA1; BRCA2; Risk-reducing surgery; Oral Contraceptives

Outcome Measures

Primary Outcomes (1)

• Differences in cell proliferation as measured by Ki67 immunohistochemical analysis in the fallopian tube fimbriae of women on the OC arm compared to women on the no treatment arm.

  Cell proliferation (Ki67) will be measured in the specimen that is removed as part of the patients surgery (the surgery is not a study procedure).

Secondary Outcomes (1)

• Cell proliferation as measured by Ki67 immunohistochemical analysis in ovarian cortical inclusion cysts of women on the OC arm compared to women on the no treatment arm.

  Cell proliferation (Ki67) will be measured in the tissue removed as part of the surgery (the surgery is not a study procedure)

Study Arms (2)

No intervention

NO INTERVENTION

No intervention.

OrthoNovum 1/35

ACTIVE COMPARATOR

OrthoNovum 1/35

Drug: OrthoNovum 1/35

Interventions

OrthoNovum 1/35 DRUG

OrthoNovum 1/35

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal
• and 45 years of age
• Scheduled to undergo a laproscopically conducted RR-BSO, risk reducing salpingectomy, salpingectomy for sterilization, or salpingectomy with hysterectomy for non-cancer related conditions
• Have at least one ovary

You may not qualify if:

• Past hysterectomy
• Past diagnosis of ovarian cancer
• Use of Tamoxifen, Raloxifene or hormone replacement therapy in the past 3 months
• Use of Chemotherapy in the last 6 months

Sponsors & Collaborators

• University of Michigan: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

USC Keck School of Medicine

Los Angeles, California, 90089, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

UBC BC Cancer Agency

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Study Officials

• Celeste L Pearce, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)