## Protocol Section
### Identification Module
**NCT ID:** NCT01486979

**Brief Title:** Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

**Official Title:** A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis

#### Organization Study ID Info
**ID:** VAG-1850
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**ID:** 2006-005957-31
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-02-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Start Date
**Date:** 2007-01

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2011-12-07
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-05
**Study First Submit QC Date:** 2011-12-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.

### Conditions Module

**Conditions:**

- Menopause

- Postmenopausal Vaginal Atrophy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 58

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: estradiol, 10 mcg

**Label:** Low dose

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: estradiol, 25 mcg

**Label:** High dose

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low dose

**Description:** One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks

**Name:** estradiol, 10 mcg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- High dose

**Description:** One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks

**Name:** estradiol, 25 mcg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area under the curve (AUC)

#### Secondary Outcomes

**Measure:** Average plasma concentration (C average)

**Measure:** Maximal concentration (Cmax)

**Measure:** Minimal concentration (Cmin)

**Measure:** Time of maximal concentration (tmax)

**Measure:** Incidence of adverse events

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects who are able to use German language in speaking and writing
* Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
* Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
* Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
* Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
* Availability of a normal mammogram within one year prior to trial start
* Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Known, suspected or past history of breast cancer
* Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
* Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
* Abnormal genital bleeding of unknown etiology
* Previous estrogen and/ or progestin hormone replacement therapy

**Maximum Age:** 70 Years

**Minimum Age:** 60 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Neu-Ulm

**Country:** Germany

**Facility:** Novo Nordisk Investigational Site

**Zip:** 89231

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Global Clinical Registry (GCR, 1452)

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Eugster-Hausmann M, Waitzinger J, Lehnick D. Minimized estradiol absorption with ultra-low-dose 10 microg 17beta-estradiol vaginal tablets. Climacteric. 2010 Jun;13(3):219-27. doi: 10.3109/13697137.2010.483297.

**PMID:** 20423242

#### See Also Links

**Label:** Clinical Trials at Novo Nordisk

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014623

- Term: Vaginal Diseases

- 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: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M17375

- Name: Vaginitis

- Relevance: HIGH

- As Found: Vaginitis

- ID: M29419

- Name: Atrophic Vaginitis

- Relevance: HIGH

- As Found: Atrophic Vaginitis

- ID: M17371

- Name: Vaginal Diseases

- Relevance: LOW

- As Found: Unknown

- 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

- ID: T6036

- Name: Menopause

- Relevance: HIGH

- As Found: Menopause

### Condition Browse Module - Meshes

- ID: D000014627

- Term: Vaginitis

- ID: D000059268

- Term: Atrophic Vaginitis

### 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

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M8108

- Name: Estradiol

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M8116

- Name: Estrogens

- 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: M6494

- Name: Contraceptive Agents

- 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

### Intervention Browse Module - Meshes

- ID: C000007630

- Term: Estradiol 17 beta-cypionate

- ID: C000074283

- Term: Estradiol 3-benzoate

- ID: D000004958

- Term: Estradiol

- ID: C000008958

- Term: Polyestradiol phosphate

### Misc Info Module

- Version Holder: 2024-05-24
