## Protocol Section
### Identification Module
**NCT ID:** NCT00999479

**Brief Title:** Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation

**Official Title:** Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation

#### Organization Study ID Info
**ID:** Endometrioma
#### Organization
**Class:** OTHER
**Full Name:** University of Oklahoma
### Status Module
#### Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-12-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-12-09

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Start Date
**Date:** 2009-10

**Status Verified Date:** 2013-12

#### Study First Post Date
**Date:** 2009-10-21
**Type:** ESTIMATED
**Study First Submit Date:** 2009-10-20
**Study First Submit QC Date:** 2009-10-20
**Why Stopped:** Poor enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Oklahoma

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to determine whether or not continuous combined oral contraceptive pills (COCP's) decrease the risk of recurrent endometrioma formation. The investigators' hypothesis is that patients who have endometriomas surgically removed and then are started on COCP's will have a decreased incidence of recurrent endometrioma formation. The investigators' research protocol is designed to show a statistically significant decreased incidence of endometrioma formation in the hopes that physicians will use COCP's in patients they have removed an endometrioma in who do not desire immediate fertility. Long term, the investigators hope to establish a standard of care that COCP's be used postoperatively in appropriate candidates to decrease the chance of recurrent endometrioma formation.

**Detailed Description:** We plan to identify patients planning to undergo conservative surgery for endometrioma at the University of Oklahoma private practice OB/GYN clinic and at the University of Oklahoma Resident Women's clinic. After clear and appropriate consent and discussion regarding options, we plan to randomize patients to monophasic OCPs vs. placebo following surgery. We plan to enroll 35 patients in each arm and follow them for 24 months following the surgery. Surveillance with pelvic exam and transvaginal ultrasonography will occur at 2, 6 and 12 months. The patients surgery will be done prior to enrolling in our study. We will use information from their surgery only to confirm the diagnosis of endometrioma. The only procedure the subjects will undergo during the protocol are periodic transvaginal ultrasonography.

### Conditions Module

**Conditions:**

- Endometrioma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized to this study arm will receive combined oral contraceptive pills. Patients will follow up at 2, 6, 12, 18 and 24 months. On follow up visits pts will have clinical assessment with vaginal and rectal examinations and with transvaginal ultrasonography. As a measure of compliance, patients will return their empty pill packages

**Intervention Names:**

- Drug: Norethindrone acetate and ethinyl estradiol tablets, USP

**Label:** Monophasic OCP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients assigned to this arm will use non-hormonal, barrier contraceptives to prevent pregnancy.Patients will follow up at 2, 6, 12, 18 and 24 months. On follow up visits pts will have clinical assessment with vaginal and rectal examinations and with transvaginal ultrasonography. As a measure of compliance, patients will return their empty pill packages.

**Intervention Names:**

- Drug: ferrous fumarate (placebo) tablets

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Monophasic OCP

**Description:** Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.

Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each white tablet also contains the following inactive ingredients: acacia, lactose, magnesium stearate, starch, confectioner's sugar, and talc.

**Name:** Norethindrone acetate and ethinyl estradiol tablets, USP

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.

**Name:** ferrous fumarate (placebo) tablets

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation.

**Time Frame:** October 2011

#### Secondary Outcomes

**Measure:** Long term, we hope to establish a standard of care that COCPs be used postoperatively in appropriate candidates to decrease the chance of recurrent endometrioma formation.

**Time Frame:** October 2011

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with a diagnosis of ovarian endometriotic cyst that has been surgically excited.

Exclusion Criteria:

* Current desire to achieve pregnancy or other contraindication to combined oral contraceptive pills.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Oklahoma City

**Country:** United States

**Facility:** University of Oklahoma Health Sciences Center

**State:** Oklahoma

**Zip:** 73104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Oklahoma

**Name:** Katie M Smith, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometrioma

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Intervention Browse Module - Ancestors

- ID: D000004967

- Term: Estrogens

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000014131

- Term: Trace Elements

- ID: D000018977

- Term: Micronutrients

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BlSubst

- Name: Blood Substitutes

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M14087

- Name: Povidone

- Relevance: LOW

- As Found: Unknown

- ID: M14244

- Name: Progestins

- Relevance: LOW

- As Found: Unknown

- ID: M8145

- Name: Ethinyl Estradiol

- Relevance: HIGH

- As Found: Iodine

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M12577

- Name: Norethindrone

- Relevance: HIGH

- As Found: Page

- ID: M1841

- Name: Norethindrone Acetate

- Relevance: HIGH

- As Found: Sexual Dysfunction

- ID: M225448

- Name: Ferrous fumarate

- Relevance: HIGH

- As Found: EMA

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6501

- Name: Contraceptives, Oral, Combined

- Relevance: LOW

- As Found: Unknown

- ID: M266293

- Name: Norinyl

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000031621

- Term: Ferrous fumarate

- ID: D000004997

- Term: Ethinyl Estradiol

- ID: D000009640

- Term: Norethindrone

- ID: D000077563

- Term: Norethindrone Acetate

- ID: D000004958

- Term: Estradiol

### Misc Info Module

- Version Holder: 2024-05-24
